¹Northwestern University Medical School, Chicago, IL, USA
²Yale University School of Medicine, New Haven, CN and Dartmouth Medical School, Hanover, MA, USA
³Beth Israel Hospital and Harvard Medical School, Boston, MA, USA

ABSTRACT

In recent years, there has been increasing concern among physicians, patient advocacy groups, and media watchdogs that laser, light, and cosmetic surgery are being practiced by poorly trained professionals, with resulting preventable injuries to patients. In response, several professional organizations have developed guidelines for the delegation of laser services to nonphysician providers. These guidelines delineate appropriate qualifications for delegating physicians and nonphysician providers, and also describe the circumstances and settings in which delegation is appropriate.

Key Words:
Laser, Cosmetic Surgery, Pulsed Light, Guidelines

Historical Overview

As early as 8-10 years ago, reports documented the increasing tension between dermatologists and electrologists over the training required to perform laser hair removal, with dermatologists advocating for supervision by licensed physicians who are on-site. Some states that do not require licensing for electrologists to administer laser treatments, such as Texas, were of particular concern.^1,2 Yet concurrently, data showed that “properly trained” nurses had no greater risk than physicians of inducing undesirable outcomes, such as pigmentation change and blistering after laser hair removal with the long-pulsed alexandrite laser.³ Recent studies suggest that a proportionately greater number of complications are arising from dermatologic care delivered by physician extenders. Nearly 53% of 488 dermatologists surveyed in Texas in 20044 reported seeing a greater number of complications associated with delegation to nonphysicians. Of those surveyed, 33% asserted that they knew of such complications arising in the absence of a supervising physician on-site during treatment delivery. This confirmed earlier results of a survey of 2,400 members of the American Society for Dermatologic Surgery (ASDS) in 2001, which ascribed the preponderance of post-treatment patient complications to “nonphysician operators,” including cosmetic technicians, estheticians, and workers in medical/dental offices who performed procedures for which they were not appropriately trained, or who were inadequately supervised.⁵ Further studies under the auspices of the ASDS are ongoing. A growing body of evidence suggests that nonphysician provision of laser services and insufficient physician supervision of extenders may be jeopardizing patients, unnecessarily raising complication rates, and leaving dermatologists vulnerable to public censure and legal liability.^6,7

Training for Provision of Laser Services: Formal Guidelines and State Regulation

Several professional physician groups have attempted to delineate appropriate training standards for those using lasers on patients. Such standards have typically been embedded in larger position papers on the scope of practice or laser use. Moreover, given that even the physician leadership can differ on exactly how training standards should be implemented, these guidelines tend to be firm in tone, but vague in terms of specific benchmarks for competency.

American Academy of Dermatology

On February 22, 2004, the Board of Directors of the American Academy of Dermatology (AAD) approved a Position Statement on the Use of Lasers, Pulsed Light, Radiofrequency, and Medical Microwave Devices.8 This one-page document notes that physicians using the aforementioned devices must be trained in relevant “physics, safety, and surgical techniques.” Regarding physician and nonphysician roles during delegation of laser procedures, the following precautions should be observed:

A physician who delegates such procedures should be fully qualified by residency training and preceptorship or appropriate course work prior to delegating procedure to licensed or certified nonphysician office personnel and should directly supervise the procedures. The supervising physician shall be physically present on-site, immediately available, and able to respond promptly to any questions or problem that may occur while the procedure is being performed.

Any nonphysician office personnel employed and designated by a physician to perform a procedure must be under the direct supervision of the physician. For each procedure performed, the nonphysician office personnel must have appropriate documented training and education in the physics, safety, and surgical techniques of each system, be properly licensed in their state if required, and be adequately insured for that procedure. The nonphysician office personnel should also be appropriately trained by the delegating physician in cutaneous medicine.

In summary, the AAD document notes that the “Academy endorses the concept that use of properly trained nonphysician office personnel under appropriate supervision allows certain procedures to be performed safely and effectively.” The earlier exhortation that the supervising physician be present on-site is thus balanced by the concession that delegation of laser procedures to nonphysicians is inherently acceptable.

American Society of Laser Surgery and Medicine

The most extensive work in this area has been by the American Society of Laser Surgery and Medicine (ASLMS), which has incorporated the relevant guidelines established by the American National Standards Institute (ANSI) Z136.3 Standard Safe Use of Lasers in Healthcare Facilities.9 Regarding operator qualification in the context of laser safety, ASLMS guidelines include the following clauses:

The laser will be operated only by those who have had training in laser theory, techniques of control, and operation of the laser(s) or IPL.

A program for laser safety training will be made available to ALL personnel working around the lasers. The Laser Safety Officer shall have discretion, according to ANSI standards, in delineating which personnel are required to undergo which levels of training. All of the training shall be documented and kept on file.

ASLMS also further clarifies training requirements in documents on office-based laser procedures10 and nonphysician use of lasers.^11,12

The ASLMS Principles for Nonphysician Laser Use,11 and Educational Recommendations for Laser Use by Nonphysicians,12 reproduced below, are slightly more specific:

Principles for Nonphysician Laser Use

Any physician who delegates a laser procedure to a nonphysician must be qualified to do the procedure themselves by virtue of having received appropriate training in laser physics, safety, laser surgical techniques, pre- and postoperative care, and be able to handle the resultant emergencies or sequelae.

Any nonlicensed medical professional employed by a physician to perform a laser procedure must have received appropriate documented training and education in the safe and effective use of each laser system, be a licensed medical professional in their state, and carry adequate malpractice insurance for that procedure.

A properly trained and licensed medical professional may carry out specifically designed laser procedures only under physician supervision and following written procedures and/or policies established by the specific site at which the laser procedure is performed.

Since the ultimate responsibility for performing any procedure lies with the physician, the supervising physician should be immediately available and shall be able to respond within five minutes to any untoward event that may occur. Ultimate responsibility lies with the supervising physician.

The guiding principle for all physicians is to practice ethical medicine with the highest possible standards to ensure the best interest and welfare of each patient is guaranteed. The ASLMS endorses the concept that use of properly trained and licensed medical professionals, under appropriate supervision, allows certain laser procedures to be performed safely and effectively.

Educational Recommendations for Laser Use by Nonphysicians

Individuals should be trained appropriately in laser physics, tissue interaction, laser safety, clinical application, and pre and post operative care of the laser patient. Prior to the initiation of any patient care activity the individual should have read and signed the facilities policies and procedures regarding the safe use of lasers.

Continuing education of all licensed medical professionals should be mandatory and be made available with reasonable frequency (including outside the office setting) to help ensure adequate performance. Specific credit hour requirements will be determined by the state, and/or individual facility.

A minimum of TEN procedures of precepted training should be required for each laser procedure and laser type to assess competency. Participation in all training programs, acquisition of new skills and number of hours spent in maintaining proficiency should be well documented.

After demonstrating competency to act alone, the designated licensed medical professional may perform limited laser treatments on specific patients as directed by the supervising physician.

American College of Surgeons

Among major specialties approved by the American Council on Graduate Medical Education (ACGME), surgery has been among the most active in promulgating outlines for laser training and use. This broad field is experienced at incorporating and regulating new operative technologies, but the breadth of laser use in surgery limits the specificity of the relevant parts of the American College of Surgeons’ (ACS) Statement on Laser Surgery,13 revised in 2007 from the original statement published in 1991:

Surgery is performed for the purpose of structurally altering the human body by the incision or destruction of tissues and is a part of the practice of medicine. Surgery is also the diagnostic or therapeutic treatment of conditions or disease processes by any instruments causing localized alteration or transposition of live human tissue, which include lasers, ultrasound, ionizing radiation, scalpels, probes, and needles. All of these surgical procedures are invasive, including those that are performed with lasers, and the risks of any surgical intervention are not eliminated by using a light knife or laser in place of a metal knife or scalpel.

The American College of Surgeons believes that surgery using lasers, pulsed light, radiofrequency devices, or other means is part of the practice of medicine and constitutes standard forms of surgical intervention. It is subject to the same regulations that govern the performance of all surgical procedures, including those that are ablative or nonablative, regardless of site of service (that is, hospital, ambulatory surgery center, physician’s office, or other locations). Patient safety and quality of care are paramount, and the College therefore believes that patients should be assured that individuals who perform these types of surgery are licensed physicians (defined as doctors of medicine or osteopathy) who meet appropriate professional standards. This is evidenced by comprehensive surgical training and experience, including the management of complications, and the acquisition and maintenance of credentials in the appropriate surgical specialties (that is, board certification) and in the use of lasers, pulsed light, radiofrequency devices, or other similar techniques.

Individuals who perform laser surgery utilizing lasers, pulsed light, radiofrequency devices, or other techniques should meet the principles of the College in all respects, to include the avoidance of any misrepresentations to the public regarding unfounded advantages of the laser compared with traditional operative techniques. ¹³

Furthermore, the ACS Statement on Issues to Be Considered Before New Surgical Technology is Applied to the Care of Patients, the subsection on “Is the individual proposing to perform the new procedure fully qualified to do so?” includes the following passage:

In order to determine and apply proper indications for a procedure and to select the appropriate patients for applications of the technology, comprehensive knowledge of the disease process and experience in management of patients with the disease is essential. Prompt recognition and management of complications can only be achieved when the individual or team member is fully qualified in all aspects of treatment of the disease.14

American Society for Dermatologic Surgery

Within dermatology, the American Society for Dermatologic Surgery (ASDS) has been most active in developing guidelines for the nonphysician practice of medicine, in particular, the use of lasers. This multi-pronged approach has included alerting state medical boards to the potential hazards to patients, publishing statistical data in the professional medical literature, making information easily available to patients on the Internet, and conducting a public relations campaign to apprise patients of the dangers inherent in receiving laser services from unqualified personnel.

At present, the ASDS guidelines assert that cosmetic procedures, including cutaneous laser procedures, be delivered only by MDs and DOs who have been adequately trained. A qualified physician may delegate some procedures to certified or licensed office personnel (e.g., RN, CMA, LPN, PA, NP) if, and only if, the delegated individuals are properly trained in the specific procedure and the physician remains physically on-site and available to respond in a timely manner to questions or problems that may arise.15

In recognition of the fact that laser hair removal procedures, in particular, are likely to be performed by nonphysicians, the ASDS provides, in the public portion of its web-site, a statement entitled Don’t Get Burned – What You Need to Know About Laser Hair Removal,16 which reads in part:

• Do consult a qualified physician: Regulations for laser use have not kept up with the demand and consumers should be cautious of nonphysicians practicing these procedures in spas/salons. Only a physician who is board-certified in dermatology or another specialty with equivalent training and experience should perform this procedure or the physician can designate another trained technician to perform a procedure as long as he/she is under the direct (on-site) supervision of the physician.
• Do ask questions: What kind of lasers do they use? What kind of training or experience do they have? Can you speak with one of their clients? If the person performing the procedure can’t answer these simple questions, you should walk away.
• Do ensure the physician has experience with different skin types: People of a darker complexion may experience unusual lightening of the skin if an incorrect laser is used at an inappropriate setting.

State Medical Boards

State medical boards have taken notice of the media furor surrounding adverse events resulting from laser use by nonphysicians. The Louisiana State Board of Medical Examiners has begun to require that the use of medical lasers and chemical peeling procedures be under direct supervision by an on-site physician. Similarly, the New York State Board of Medicine has construed laser hair removal by lasers and intense pulsed light devices to constitute the practice of medicine, and hence to be permissible only when performed by a physician or under a physician’s direct supervision. The Massachusetts legislature established a task force within the Board of Medicine to report back to the legislature by May, 2007 with draft standards or regulations on medi-spas.

Practical Issues in Nonphysician Laser Practice: Financial Incentives, Patient Safety, and Adverse Events

From a practical standpoint, the dangers of inappropriate delegation of laser services or nonphysician practice of medicine include:

• impaired patient safety, such as
  • increased frequency of avoidable adverse events
  • failure to treat adverse events appropriately and in a timely manner;
• provision of unnecessary or inappropriate laser services
• over-treatment
• subordination of patient well-being to financial productivity of the practice.17

In the case of laser use in a spa, the financial incentives for delegation are further enhanced by the nature of the business model, which resembles a retail store rather than a medical practice, and to a greater extent than in a physician practice, service providers may be compensated on an incentive basis. There may be no physicians present at most times, and there may even be a dearth of medical personnel. In many spas, services are provided by estheticians and nonmedical, nonphysician providers, who are not inculcated as are physicians and nurses in the need to ensure patient well-being.

Problems that have been commonly seen in unsupervised or nonphysician laser centers have been numerous and varied and include:

• burns associated with excessive treatment levels
• burns and post-treatment hyperpigmentation associated with treatment of tanned individuals
• scarring and hypopigmentation associated with excessive treatment, multiple passes, or cooling excess or failures
• delayed healing, erosions, and ulceration associated with untreated herpes simplex infection or impetigo
• configurate linear and round patterning of the skin associated with improper treatment resulting in tattooing with the laser handpiece
• corneal and retinal injury due to inadequate use of eye protection.

Some of these problems, like hyperpigmentation, will eventually resolve, but hypopigmentation and configurate scarring can be persistent and disfiguring. Rampant infection can result in functional loss, including permanent impairment of facial sensory structures.

The problem of impaired safety is exacerbated by the lack of general dermatologic training among nonphysician providers of laser services. In general, low-level and even some high-level nonphysician providers are trained mostly in the technique of laser service delivery, with lesser training in the management of adverse events, and little or no training in general cutaneous medicine. Adverse events, and especially unusual cases, may be recognized late by such providers, who may then treat them incorrectly. Especially when physician supervision is light, incorrect treatment may continue for some time, until the problem has worsened and permanent sequelae may be inevitable. It is a truism in cutaneous laser therapy that firing a laser handpiece may be the least important portion of the treatment; it is everything but the actual treatment, including patient selection, parameter selection, and recognition and management of undesirable outcomes, that requires judgment and training. In the spa environment or in a poorly supervised laser practice, the pressure to “convert” all consultations into treatments may result in poor patient selection, which in turn may dramatically increase the rate of adverse events.

Incentives for nonphysician providers to maximize revenue generation in a spa or thinly supervised setting can increase the risk of adverse events by:

• hurrying preoperative evaluation and laser treatment.
• encouraging the treatment of patients who may be poor laser candidates.

To the extent that nonphysician providers may have a skewed financial incentive structure, wherein they are more often rewarded for revenue generation than penalized for adverse events and patient dissatisfaction, the impetus to increase business may dominate. The result means greater risk for the patient, and for the ostensibly delegating but possibly off-site physician, who may have medico-legal responsibility for problems accruing from delegated services.

Beyond adverse events, such incentives may lead to unnecessary treatments motivated by the desire to increase financial yield by extending the number of sessions. Indeed, more revenue may be generated by systematically undertreating patients to ensure that they return for more visits. Subtherapeutic treatments may also reduce the risk of adverse events when laser treatments are delivered by minimally trained nonphysician providers. While undertreatment is unlikely to cause irrevocable physical injury, it is a form of fraud that wastes patients’ time and money.

Conclusions

While current guidelines on appropriate cutaneous laser training and delegation are not detailed and comprehensive, some recommendations occur repeatedly in guidelines proposed by various national professional organizations. In particular, it is apparent that:

• optimal laser use occurs when a physician who is trained in a relevant specialty, with additional training for the specific laser to be used, directly performs laser services on an appropriately selected patient.
• laser training of nonphysician providers should be comprehensive and not limited to merely delivering a technical service, but should include theoretical and practical training, and should encompass an understanding of patient selection, adverse events, and appreciation of the limits of this training.
• even when nonphysician personnel are appropriately trained, delegation of laser use should occur in the context of adequate physician oversight under ideally direct, on-site supervision. In medicine, a quest for efficiency or revenue maximization by an individual or corporate entity can never supersede the responsibility to ensure patient safety.
• in medicine, a quest for efficiency or revenue maximization by an individual or corporate entity can never supersede the responsibility to ensure patient safety.

References

1. Wagner RF Jr, Brown T, Archer RE, Uchida T. Dermatologists attitudes toward independent non-physician electrolysis practice. Dermatol Surg 24(3):357-62 (1998 Mar).
2. Wagner RF Jr, Brown T, McCarthy EM, McCarthy RA, Uchida T. Dermatologist and electrologist perspectives on laser procedures by non-physicians. Dermatol Surg 26(8):723-7 (2000 Aug).
3. Freedman BM, Earley RV. Comparing treatment outcomes between physician and nurse treated patients in laser hair removal. J Cutan Laser Ther 2(3):137-40 (2000 Sep).
4. Friedman PM, Jih MH, Burns AJ, Geronemus RG, Kimyai-Asadi A, Goldberg LH. Nonphysician practice of dermatologic surgery: the Texas perspective. Dermatol Surg 30(6):857-63 (2004 Jun).
5. Brody HJ, Geronemus RG, Farris PK. Beauty versus medicine: the nonphysician practice of dermatologic surgery. Dermatol Surg 29(4):319-24 (2003 Apr).
6. Goldberg DJ. Legal considerations in cosmetic laser surgery. J Cosmet Dermatol 5(2):103-6 (2006 Jun).
7. Goldberg DJ. Legal issues in laser operation. Clin Dermatol 24(1):56-9 (2006 Jan-Feb).
8. Board of Directors of the American Academy of Dermatology. Position Statement on the Use of Lasers, Pulsed Light, Radiofrequency, and Medical Microwave Devices. American Academy of Dermatology; (2004 Feb 22).
9. ANSI Z136.3-2005 Standard for the Safe Use of Lasers in Health Care Facilities. American National Standards Institute; (2005).
10. Board of Directors, American Society of Laser Medicine and Surgery. ASLMS Guidelines for Office-Based Laser Procedures. American Society of Laser Medicine and Surgery; (1999 Apr 15).
11. Board of Directors, American Society of Laser Medicine and Surgery. ASLMS Principles for Non-Physician Laser Use. American Society of Laser Medicine and Surgery; (1999 Apr 15).
12. Board of Directors, American Society of Laser Medicine and Surgery. ASLMS Education Recommendations for Laser Use by Nonphysicians. American Society of Laser Medicine and Surgery; (1999 Apr 15).
13. Statement on Laser Surgery [ST-11]. Bull Am Coll Surg 92(4) (2007 Apr).
14. Statement on Issues to be Considered Before a New Surgical Technology is Applied to the Care of Patients [ST-23]. Bull Am Coll Surg 80(9):46-7 (1995 Sep).
15. Bryant R. ASDS gears up for expanded campaign: society sees escalating issues with nonphysician care. Dermatol Times (2004 Jun 1).
16. ASDS. Do’s and Don’ts: Don’t get burned: What you need to know about laser hair removal. American Society for Dermatologic Surgery; (2007 Mar 3). URL: www.asds-net.org.
17. Alam M. Who is qualified to perform laser surgery and in which setting? Sem Cutan Med Surg, in press (2007).

1. Section of Cutaneous and Aesthetic Surgery, Department of Dermatology, Northwestern University, Chicago, USA
2. SkinCare Physicians of Chestnut Hill, Chestnut Hill, MA, USA
3. Department of Medicine (Dermatology), Dartmouth Medical School, Hanover, NH, USA
4. Department of Dermatology, Yale University School of Medicine, New Haven, CT, USA

ABSTRACT

Acne scarring is common but surprisingly difficult to treat. Scars can involve textural change in the superficial and deep dermis, and can also be associated with erythema, and less often, pigmentary change. In general, treatment of acne scarring is a multistep procedure. First, examination of the patient is necessary to classify the subtypes of scarring that are present. Then, the patient’s primary concerns are elicited, and the patient is offered a menu of procedures that may address the various components of the scarring process. It is important to emphasize to the patient that acne scarring can be improved but never entirely reversed.

Key Words:
acne scars, ablative resurfacing, nonablative resurfacing, skin fillers, surgical excision

Classification of Acne Scars

There are several classifications of acne scars. A recent, comprehensive and functional scheme was proposed,1 whereby scars are classified as rolling, ice-pick, shallow box-car, and deep box-car. Rolling scars are gently undulating, appearing like hills and valleys without sharp borders. Ice-pick scars, also known as pitted scars, appear as round, deep depressions culminating in a pinpoint base; in cross-section, they are shaped like a “v.” Box-car scars have a flat, “u-shaped” base. Broader than ice-pick scars, they are round, polygonal, or linear at the skin surface. Shallow box-car scars terminate in the shallow-to mid-dermis, and deep box-car scars penetrate to the reticular dermis.

Treatment Modalities for Textural Change

Among the therapeutic tools for treatment of acne scarring are resurfacing methods, fillers, and other dermal remodeling techniques. These methods can be adapted to treat specific scar types.

Resurfacing

Resurfacing options include:

• Ablative resurfacing with carbon dioxide or erbium:
  yttrium aluminum garnet (Er:YAG) laser, medium- depth to deep chemical peel, dermabrasion, or plasma
• Nonablative and partially ablative resurfacing with fractional laser, infrared laser (1,320nm neodymium:YAG (Nd:YAG), 1,450nm diode, or 1,540nm erbium:Glass)

Ablative Resurfacing

Ablative resurfacing entails removal of the epidermis and partial thickness dermis, and is considered by most as the gold standard for pitted scars and some box-car scars. While ablative resurfacing is most effective if it is deep, thereby removing as much as possible of the depressed scar, it cannot be so deep as to destroy the base of the hair follicles; such destruction could impede skin regrowth, and induce scar formation at the treated site. Carbon dioxide resurfacing is the most effective but also most operator-dependent method for deep ablative resurfacing.² Dermabrasion is possibly even more effective, but this is another procedure that is very technique dependent. Deep phenol (Baker-Gordon) peels, also highly effective, have fallen out of favor because of the associated cardiac risk and the frequency of porcelain-white postinflammatory hypopigmentation. Definitive ablative resurfacing results in 2 weeks of patient downtime, during which period re-epithelialization occurs.³ More superficial resurfacing with the Er:YAG laser or plasma can provide recovery within 1 week, but deeper acne scars may be less improved.

Nonablative Resurfacing

Nonablative resurfacing with laser and lights warms the dermis and can provide modest improvement of acne scarring by stimulating collagen remodeling. All subtypes of acne scars can be improved by nonablative therapy. Among the lasers used for this indication are devices originally developed for other uses, such as pulsed-dye lasers, intense pulsed light devices, and Q-switched Nd:YAG lasers. However, more recently nonablative devices have been optimized to specifically target textural irregularities. For example, a series of treatments with infrared lasers can significantly improve uneven contour associated with acne scarring.⁴ These treatments are typically uncomfortable and may require oral and/or topical analgesics.

Similarly, fractional resurfacing is quite effective in the treatment of acne scarring. Fractional resurfacing is a minimally ablative technique that creates microscopic zones of dermal injury in a grid-like pattern.⁵ Because only a small proportion of the skin surface is treated at one time, and since the stratum corneum is not perforated, recovery is quick. However, a series of treatments is needed.

Fillers

During the past 5 years, many new injectable prepackaged soft-tissue augmentation materials have become available in the US. Among these are the so-called linear fillers, which permit fine correction of individual lines and depressions: human collagen, hyaluronic acid derivatives, calcium hydroxylapatite (off-label use), and silicone (off-label use).

Injectable linear fillers can enable short-, medium-, or long-term correction of acne scars. Large-particle fillers such as calcium hydroxylapatite have a longer persistence in vivo and are appropriate for larger areas of rolling scars; thicker fillers must be injected no higher than the dermal subcutaneous junction. Collagen or hyaluronic acid products can be injected directly beneath individual pitted or box-car scars, or be used to buttress areas of rolling scars. Patients should be advised that the duration of action varies, with collagen lasting 2-3 months, hyaluronic acid products, 4-6 months, and calcium hydroxylapatite, 1 year. Volumetric fillers, such as poly-L-lactic acid, may not be appropriate for acne scars, except for rolling scars. By definition, volumetric fillers are designed to correct skin and subcutaneous wasting over wide areas rather than individual fine textural abnormalities.

Injectable silicone is a controversial product gaining new acceptance as a filler for correction of acne scars, especially pitted and box-car scars.6 Now approved by the US FDA for intraocular tamponade, medical-grade silicone is used off-label for permanent correction of acne scars. To avoid delayed hypersensitivity and immune reactivity, very small aliquots of 0.01ml, known as “microdroplets”, are used, and placement is sparse. Repeat treatments with small quantities enable gradual complete correction. The inconvenience of numerous treatments, as well as the theoretical risks of adverse events are mitigated by the promise of permanence.

Excision and Subcision

Ice-pick and box-car scars may also be removed by surgical excision. This technique may entail punch excision of a given small acne scar with a punch biopsy instrument of equal or slightly greater diameter. Then one or two 5.0 or 6.0 simple interrupted sutures are used to close the resulting defect, with the attendant transformation of a round, indented scar into a flat slit-like scar. Larger linear box-car scars can be excised by elliptical excision and repaired by bilayered closure. Sufficient eversion is necessary to avoid recurrence of an indented groove.

Alternatively, after punch excision of a small scar, the defect may be filled by a punch graft. Harvested from another area, commonly the postauricular sulcus, a punch graft is pressed into the created defect and either sutured or glued in place. Punch grafting creates a secondary defect and risks poor color and texture match between donor and recipient sites. However, by filling the deadspace at the excision site, punch grafting may reduce the likelihood that scar excision and closure will fail because of excessive tension in the closure.

Subcision treats rolling scars by separating the fibrous bands securing them to the deep dermis.7 A sharp device, often an 18-gauge Nokor^® needle with a spear-like tip, is inserted at an angle into the dermis at a distance of 1–2cm from the scar. The needle tip is aimed upward, tenting but not puncturing the skin, and is advanced to a point under the scar. Backward and forward rasping of the underside of the dermis beneath the scar is used to sever fibrous bands while initiating a reactive fibrosis that gradually, over several weeks, propels the depressed scar upwards. Bruising following subcision can last 1–2 weeks, but the procedure is well-tolerated with local infiltration of anesthetic. A benefit of subcision is the absence of any epidermal injury, except for minute needle insertion points.

Treatment Modalities for Color Change

Laser and light sources can be used to improve acne-associated color change, especially erythema. Difficult-to-correct textural abnormalities associated with acne scarring can be camouflaged by reducing the ring of redness around such scars. The redness accentuates the depth of the scar and focuses the observer’s attention, but removal of the redness can make the scar seem less deep and noticeable, even if the depth and size are objectively unchanged. Pulsed-dye laser,⁸ KTP laser, and intense pulsed light devices can be used for treatment of peripheral redness around acne scars. Usually, 3–4 or more treatments are required, at approximately 1 month intervals.

Brown discoloration around acne scars tends to occur in darker-skinned patients and is usually postinflammatory. As with all postinflammatory hyperpigmentation, the treatment of choice is the passage of time. Managing any residual active acne is also crucial, as further acne lesions will give rise to additional pigmentation. In some cases, a topical bleaching agent, such as 4% hydroquinone, may be appropriate adjuvant therapy.

Caveats and Cautions

Before commencing treatment of acne scars, in-depth discussion with the patient is necessary. It is crucial to communicate the fact that acne scars are seldom completely or almost completely removed, and that several procedures may be required to collectively provide the optimal correction. The patient’s willingness to incur downtime must also be clarified since some procedures, like ablative resurfacing, may require post-treatment resting at home for up to 2 weeks. Patients with active acne should not be treated for acne scarring. Many acne scarring treatments, like resurfacing, excision, and subcision, can exacerbate acne, even stimulating the production of nodulocystic lesions. Those with active acne should be reassured that the physician is not abandoning them, and remains interested in treating their acne scarring. First, however, they must undergo treatment for their acne, which should be quiescent for at least 6 months to 1 year before therapy for the scarring is begun.

Finally, darker-skinned patients with Fitzpatrick skin types IV-VI are at risk for procedure-related hyperpigmentation. Asian, Mediterranean, and African-American patients can have diffuse, widespread hyperpigmentation lasting a year or more after laser resurfacing. Excision procedures can induce a similar problem. In susceptible patients, nonablative resurfacing, fillers, and subcision may be preferred, unless the patient is otherwise a candidate for ablative resurfacing, and also indicates a willingness to endure protracted hyperpigmentation.

Conclusions

Acne scarring is a complex problem that is not amenable to a simple, definitive solution. Depending on specific patient features and preferences, a combination of several treatment procedures may be appropriate. A therapeutic alliance with the patient is necessary to ensure patience and compliance during the often long, and occasionally frustrating, treatment course.

References

1. Jacob CI, Dover JS, Kaminer MS. Acne scarring: a classification system and review of treatment options. J Am Acad Dermatol 45(1):109-17 (2001 Jul).
2. Batra RS, Jacob CI, Hobbs L, Arndt KA, Dover JS. A prospective survey of patient experiences after laser skin surfacing: results from 2½ years of follow-up. Arch Dermatol 139(10):1295-9 (2003 Oct).
3. Alam M, Pantanowitz, Harton AM, Arndt KA, Dover JS. A prospective trial of fungal colonization after laser resurfacing of the face: correlation between culture positivity and symptoms of pruritus. Dermatol Surg 29(3):255-60 (2003 Mar).
4. Bhatia AC, Dover JS, Arndt KA, Steward B, Alam M. Patient satisfaction and reported long-term therapeutic efficacy associated with 1,320nm Nd:YAG laser treatment of acne scarring and photoaging. Dermatol Surg 32(3):346-52 (2006 Mar).
5. Geronemus RG. Fractional photothermolysis: current and future applications. Lasers Surg Med 38(3):169-76 (2006 Mar).
6. Barnett JG, Barnet CR. Treatment of acne scars with liquid silicone injections: 30-year perspective. Dermatol Surg 31(11 Pt 2):1542-9 (2005 Nov).
7. Alam M, Omura N, Kaminer MS. Subcision for acne scarring: technique and outcomes in 40 patients. Dermatol Surg 31(3):310-7 (2005 Mar).
8. Alster TS, McMeekin TO. Improvement of facial acne scars by the 585nm flashlamp-pumped pulsed-dye laser. J Am Acad Dermatol 35(1):79-81 (1996 Jul).

During 2006, the reviewers noted below gave generously of their time and talents and completed manuscript reviews for the Skin Therapy Letter. On behalf of the Editorial Advisory Board and our readership, we thank them for their efforts.

Stuart Maddin, MD, FRCPC
Editor-In-Chief

• Murad Alam
• Ken Arndt
• Melissa Bogle
• Jan D. Bos
• Marc Bourcier
• Joel Claveau
• Jeffrey S. Dover
• George Hruza
• Ian Landells
• Charles W. Lynde
• Catherine McCuaig
• Régine Mydlarski
• Yves Poulin
• Jerry Tan
• Richard Thomas
• Ron Vender
• Beatrice Wang
• Catherine Zip

Fractional laser treatment with the 1,550nm erbium fiber laser (Fraxel^® Laser, Reliant Technologies) has bridged the gap between the ablative and nonablative laser modalities used to treat the epidermal and dermal signs of skin aging. By targeting water as its chromophore, the laser induces a dense array of microscopic, columnar thermal zones of tissue injury that do not perforate or impair the function of the epidermis. The significant skin remodeling that ensues can be used to treat, with limited downtime, epidermal pigmentation, melasma, and rhytides, as well as textural abnormalities that include acne-related and surgical scars.

Key Words:
ablative laser, pigmentation, textural abnormalities, photoaging, acne scars, surgical scars

Although ablative laser modalities remain the gold standard for the treatment of photoaging, most patients cannot tolerate the 1–2 weeks of downtime required with these procedures. Additionally, ablative skin treatment carries the risks of pigmentary alteration, infection, and scarring. At the other end of the spectrum, nonablative modalities induce collagen remodeling through deep dermal heating, yet have no epidermal resurfacing effect.

The Fraxel^® Laser is a 30watt, diode pumped, 1,550nm erbium fiber laser that targets water as its chromophore. Utilizing the concept of fractional treatment 70–100um wide and 250–800um deep, microthermal zones (MTZs) of tissue coagulation are produced. Tissue is not vaporized and the stratum corneum remains intact. The epidermal coagulated tissue is expelled and replaced by keratinocyte migration. When there is significant damage to the basement membrane zone, dermal contents are also expelled as microscopic epidermal and dermal necrotic debris (MENDs). In this way, epidermal and dermal pigmentation can be treated without specifically targeting melanin as the chromophore. Zones of collagen denaturation in the dermis cause upregulation of the inflammatory cascade, which leads to collagen remodeling and new collagen formation.

In the first study of the fractional laser, 15 subjects received treatments of varying densities at test sites
on the distal forearm. Biopsies were taken from the treated tissue at intervals of 48 hours, 1 week, 1 month, and 3 months in order to identify MTZs and to characterize the wound healing process.¹ This data supported the use of the device for coagulation of soft tissue and, in November 2003, the US FDA approved it for that purpose. Since then, the fractional laser device has received additional FDA clearance for the treatment of periorbital rhytides, pigmented lesions, melasma, skin resurfacing, acne scars, and surgical scars.

The fractional laser contains an intelligent optical tracking system that utilizes OptiGuide Blue^™ tint, a water soluble FDC dye. The optical mouse in the laser handpiece recognizes subtle differences in the density of blue dye on the skin’s dermatogliphs. The mouse communicates with the laser to lay down an even MTZ spot pattern independent of handpiece velocity. This system allows for a more even placement of MTZs, which is important in fractional tissue treatment where the optimal spacing between lesions allows for rapid re-epithelialization and prevents negative sequelae associated with fully ablative treatment at depths of 300–800um. The dye can be challenging to remove in patients with enlarged pores or with hyperkeratotic lesions, such as actinic keratoses. The use of a dimethicone-based sealant prior to blue dye application can assist in removal of the dye. Blue dye is best removed with a foam-based skin cleanser that increases the surface area of the surfactant in contact with the skin.

Pain Management

Pain management is one of the most significant hurdles of the procedure. Discomfort from the laser treatment is managed by use of topical anesthetics, e.g., LMX-5^®, EMLA^® (AstraZeneca), and other lidocaine/tetracaine formulations, such as 7% lidocaine/ 7% tetracaine (S-Caine^™, ZARS), prior to procedure.

Forced air cooling (Zimmer Cryo 5^®, Zimmer Medizin Sytems), which is often used concurrently with fractional laser treatment,² increases patient comfort significantly. Histologic analysis reveals a slight reduction in thermal damage zone width, but no statistically significant change in lesion depth. Forced cooled air should be used at the lowest possible setting to minimize alteration in the MTZs. When treating for superficial indications such as pigmentation and melasma, Zimmer settings should be 1–2. When treating deeper indications such as deep rhytides or scars, higher forced air settings, in combination with higher laser settings, may be used.

Oral anxiolytics and analgesics may be required in a small minority of patients who cannot tolerate the procedure with topical anesthetic alone.

Treatment Protocols by Indication

The current recommended treatment protocols are listed in Table 1. Important concepts to consider when using the fractional laser device are treatment energy, density, coverage, volume of tissue treated, and treatment intervals. The first three concepts, energy, density, and coverage, are closely related. The depth and width of the MTZs are proportional to energy. These are displayed in Figures 1 and 2. In order to achieve the desired coverage, densities should be lowered for higher energy treatments. For example, a 10mJ, 2,000MTZ/cm² treatment and a 20mJ, 1000MTZ/cm² treatment both have 20% coverage.

However, the 20mJ treatment results in twice the volume of tissue treated. This is important when treating deeper indications such as scars or deep rhytides. Treatments can be spaced as close as 1 week and as far apart as 6 weeks. Higher energy treatments should be spaced every 2–4 weeks.

Figure 1: Depth coagulation at 8mJ

Figure 2a: Depth coagulation at 20mJ, 100X magnification

Figure 2b: Depth coagulation at 20mJ, 200X magnification

The energy counter on the machine allows the user to determine whether an adequate treatment has been performed. The calculations require knowledge of treatment energy, surface area treated, and total number of kJs used. On average, a full face treatment requires 5–8kJ.

Photodamage, Including Pigmentation and Rhytides

Treatment of dynamic wrinkles should include a combination approach, limiting muscle movement through the injection of neuromodulators. One “targeted” treatment for photodamage of the face uses higher energies in areas of deeper rhytides, such as in the perioral or periorbital region.³ The forehead, cheeks, and nose can be treated at lower energies. Off-face resurfacing should be performed at lower energies, as well, except when treating acne scars or other indications requiring deeper penetration. Treatment algorithms can be tailored to suit patient expectations and the targeted
indication. A greater number of “gentler” treatments (5+) with less downtime are required to achieve the same cumulative results as fewer (perhaps 4) “high-level” treatments that entail greater downtime. The probability of achieving 100% tissue coverage is far greater with five 20% treatments than with ten 10% treatments. This is due to the probability of targeting the same site with subsequent treatments. Clinical photographs of two patients reveal improvement of pigmentation and rhytides following a series of Fraxel^® treatments. (See figures 3, 4, and 5.)

Figure 3 : Treatment to improve pigmentation and rhytides using the Fraxel® Laser at baseline and after 4 treatments at 8mJ, 2,500MTZ/cm². Perioral: 15mJ, 1,500MTZ/cm²

Figure 4 : Treatment to improve pigmentation and rhytides using the Fraxel^® Laser at baseline and after 4 treatments

Figure 5 : Treatment to improve pigmentation and rhytides using the Fraxel® Laser at baseline and after 4 treatments

Scars (Acne and Surgical)

Comparative data evaluating high vs. low energy treatments shows improved results with higher energy treatments.4 Regardless of the energy used, the same percentage of the epidermis is treated. However, the use of high energies for deeper targets is based on the principle of a larger volume of tissue treated at higher energies. At equal surface area coverage of 20%, a 20mJ treatment treats twice the volume of tissue as a 10mJ treatment. This explains the greater efficacy seen for deep rhytides and acne scars with higher energy treatments. A clinical result of a Fitzpatrick skin type V patient undergoing treatment for acne scarring is shown in Figure 6.

Figure 6 : Treatment of acne scarring using the Fraxel^® Laser at baseline and 1 month after 5 treatments q2wks, 15mJ, 1,500MTZ/cm²

Melasma

Results in the treatment of melasma are encouraging. Before this treatment is commenced, the underlying etiology and hormonal factors should be elucidated. All patients should be placed on a bleaching regimen, must practice strict sun avoidance, and use high SPF sunscreens. Retinoids should be stopped 1 week prior to treatment as they blunt the heat shock response, which is essential to rapid reepithelialization following tissue injury.

Ideally, patients should be treated monthly at low energies of 6–8mJ at 1,000-2,000MTZ/cm².⁵ Melasma patients usually require fewer total treatments. A regimen of 2–3 total treatments with a “touch-up” at 6 months is commonly prescribed, although touch-up treatments are not always necessary. There is a risk of postinflammatory change, particularly in those patients who have hyperactive melanocytes. In our experience, the postinflammatory changes that occur following treatment are likely more homogeneous and better tolerated than the mottled, uneven pigmentation of melasma. Melasma can be recurrent, particularly when the causative melanocytes and hormonal profile are present.

Side-effects and Postoperative Care

Postoperatively, patients can apply sunscreen and/or makeup. There is no oozing because there is no disruption in the stratum corneum, however some patients may experience excessive desquamation and even some crusting following an aggressive treatment. The majority of patients experience some degree of erythema, which resolves within 2–3 days following a gentle to modestly aggressive treatment. Erythema may persist for up to 1 week after more aggressive treatments.

Post-treatment edema is very patient-dependent. Some have little swelling. The average patient experiences edema for 1–3 days; < 5% of patients have swelling for up to 1 week. The risk of edema also increases with higher level treatments. The majority of patients do well by applying ice at 10 minute intervals for the first 24 hours after treatment, and by sleeping on extra pillows. Although some physicians advocate the use of topical or short course systemic corticosteroids following treatment, the inflammatory cascade that leads to subsequent upregulation of collagen production may be best left unaltered.

There is always a risk of postinflammatory pigmentary alteration following any type of inflammatory process in the skin, and fractional laser treatments are no exception. Our own experience indicates an approximately 10%–12% incidence of hyperpigmentation after fractional treatments. This is most common in patients with a history of postinflammatory hyperpigmentation (PIH) or melasma. PIH is more common in patients of darker skin types (IV–V). A precautionary 6-week pretreatment with hydroquinone and a strict sun-protection regimen are advisable for these individuals.

Bulk heating can result from treating too large a fraction of the skin at one time, or from inadequate cooling between laser passes. To reduce this risk, the density of MTZs per pass should be halved to 125MTZ/cm2 when using energies above 15mJ. Treating a small area without allowing the skin to cool between passes can lead to bulk heating, even at lower energies. Treatment of >35%–40% of the skin in a single session may lead to adverse sequelae. Maintaining sufficient normal tissue between the deep zones of coagulated epidermis and dermis is essential for rapid healing following fractional treatments.

Conclusions

Fractional laser resurfacing is a safe and effective modality for the treatment of epidermal pigmentation and wrinkles associated with photoaging, melasma, and acne scars. Two years of clinical data and studies have allowed for optimization of treatment parameters with improved patient outcomes. In comparison with traditional ablative modalities, fractional laser treatment may be used to resurface any nonfacial part of the body, but is particularly useful on the neck, chest, and hands. For selected applications, fractional laser treatments may have greater efficacy than some other nonablative modalities, however they have a similar, limited downtime.

References

1. Manstein D, Herron GS, Sink RK, Tanner H, Anderson RR. Fractional photothermolysis: a new concept for cutaneous remodeling using microscopic patterns of thermal injury. Lasers Surg Med 34(5):426-38 (2004).
2. Fisher GH, Kim KH, Bernstein LJ, Geronemus RG. Concurrent use of a handheld forced cold air device minimizes patient discomfort during fractional photothermolysis. Dermatol Surg 31(9 Pt 2):1242-4 (2005 Sep).
3. Rahman Z, Rokhsar CK, Tse Y, Lee S, Fitzpatrick R. The treatment of photodamage and facial rhytides with fractional photothermolysis. Lasers Surg Med 36(suppl 17):32 (2005).
4. Rahman Z, Tanner H, Jiang K. Treatment of atrophic scars with the 1550nm erbium-fiber fractional laser. Lasers Surg Med 38(suppl 18):24 (2006).
5. Tannous ZS, Astner S. Utilizing fractional resurfacing in the treatment of therapy-resistant melasma. J Cosmet Laser Ther 7(1):39-43 (2005 Mar).

J. S. Dover, MD, FRCPC^1-3, A. Carruthers, MD, FRCPC⁴, J. Carruthers, MD, FRCSC⁵, M. Alam, MD^6
1SkinCare Physicians of Chestnut Hill, Chestnut Hill, MA, USA
²Department of Medicine (Dermatology), Dartmouth Medical School, Hanover, NH, USA
³Department of Dermatology, Yale University School of Medicine, New Haven, CT, USA
⁴Division of Dermatology, University of British Columbia, Vancouver, BC, Canada.
⁵Department of Ophthalmology, University of British Columbia, Vancouver, BC, Canada.
⁶Section of Cutaneous and Aesthetic Surgery, Department of Dermatology, Northwestern University, Chicago, IL, USA

ABSTRACT

There is no ideal filler, nor will there be a single product that can satisfy all requirements. However, RESTYLANE^®, a non-animal, stabilized hyaluronic acid (NASHA, Medicis), is a very versatile augmenting agent. It has been in clinical use for 8 years and experience has shown it to be close to the ideal filler in many respects. This review will outline the background to the use of RESTYLANE^®, and will focus on the clinical use of this material.

Key Words: filler, hyaluronic acid, NASHA

The pace of development of filler substances in the last few years has been phenomenal. Consider that for more than 20 years there was only one US FDA approved cutaneous filler device, bovine collagen (Zyderm^®/Zyplast^®, Inamed Aesthetics). Bovine collagen has several distinct disadvantages. Two skin tests are necessary, producing a minimum 4- to 6-week treatment delay between the initial consultation and the first treatment. Results are short lived, and the thickest collagen, Zyplast^®, lasts only 2-4 months. Beading is relatively common because the product becomes firm and nonmalleable soon after injection.

In February 2003, human collagen (Cosmoderm?/Cosmoplast?, Inamed Aesthetics) was approved by the US FDA. In December 2003, the US FDA approved RESTYLANE^®, a cross linked nonanimal source hyaluronic acid. Two other forms of cross-linked hyaluronic acid, Hylaform^® and Hylaform^® Plus (Inamed Aesthetics) were approved by the US FDA in the summer and fall of 2004, respectively. RESTYLANE^® is made by Streptococci and Hylaform^® is derived from chickens’ combs. They also differ in the amount and degree of cross-linking, which affects, among other things, duration of effect. Many more fillers are under development, and some are pending US FDA approval.

Considering the complexity of the areas/conditions being treated, as well as the aims and desires of the individual being treated, there is no ideal filler. Futhermore, no single product will be able to satisfy all requirements. However, a product would be useful in the majority of clinical situations with the following properties:

• non-permanent but long-lasting
• have minimal side-effects
• not require allergy testing
• be easy to use/inject
• be cost-effective both to the physician and patient.

RESTYLANE^®, a non-animal, stabilized hyaluronic acid (NASHA) is not ideal, but is far closer to this set of criteria than previous fillers.

RESTYLANE^® has been available in Europe since 1996, and in Canada since 1998. It is used in more than 60 countries to correct a variety of wrinkles, lines, and contour defects and to enhance the lips. It was approved in the US in December 2003, for use in mid-to-deep dermal implantation for the correction of moderate-to-severe facial wrinkles and folds, such as the nasolabial folds.

Benefits of RESTYLANE^® include:

• having a very low allergic potential so that skin tests are unnecessary
• having a very natural look and feel
• lasting significantly longer than any of the collagens
• being moldable and very easy to work with.

Disadvantages include temporary redness and swelling at the injection site, which is most clinically significant when the lips are injected and most often resolves within 3-4 days. Allergic reactions are rare. Most of those reported occurred prior to 2000 when the level of contaminants in the product were dramatically reduced.¹

The best data on RESTYLANE^® comes from a study of 138 subjects that led to US FDA approval.² This was a bilateral paired comparison study of the efficacy and safety of RESTYLANE^® vs. Zyplast^® use in the nasolabial folds. The products were injected at baseline, followed by touch-ups as necessary to achieve “optimal cosmetic improvement”. Judging subjects’ folds using a 5-point scale (none, mild, moderate, severe, extreme), both products achieved a 1.5 point improvement. At 6 months, the RESTYLANE^® injected side still had a 1 point improvement, whereas the Zyplast^® injected side had a 1/3 point improvement. At 6 months after injection RESTYLANE^® was considered to be superior in 62% of patients vs. 8% of patients for Zyplast^®.

There were more adverse events in the Zyplast^®-treated side, but these were mainly minor lumpiness or material showing through the skin. Whereas on the RESTYLANE^®-treated side there was more swelling and tenderness (see Table 1).

Table 1: Adverse events in the Restylane^®/Zyplast^® study²

Other Forms of NASHA

The cross-linked structure of hyaluronic acid forms a gel with limitless molecular weight. This is then passed through screens with varying pore sizes to form the injectables with differing particle sizes. This difference between particle size and molecular weight is an important concept in the field of hyaluronic acid-based materials. Resulting from this, each form of cross-linked hyaluronic acid can be packaged as a number of different injectables. For example, NASHA is packaged as RESTYLANE^® Fine Lines (or RESTYLANE^® Touch), RESTYLANE^® Perlane^®, and RESTYLANE^® SubQ. Each of these products will be applicable in an appropriate clinical setting. Large studies done with hyaluronic acid show no difference in duration.2,3

Clinical Use

RESTYLANE^® is used on the face in a variety of places and for a variety of indications, so for the sake of clarity we shall discuss the uses in different categories, recognizing that, at times, this distinction can be artificial. RESTYLANE^® is a very flexible product that can be used for most of the NASHA indications but we shall indicate where we use the different forms of NASHA by preference. Care is always taken to ensure that the product is not injected into a vessel especially when injecting the periocular area.

Fine Lines

Good examples of areas where fine lines are treated would be the glabella, the cheeks, and the perioral area. In these areas we inject RESTYLANE^® in the mid-dermis or higher using a serial puncture technique. One should always feel the resistance of the dermis as one is injecting. The glabella and the perioral areas are usually treated in conjunction with BOTOX^® (botulinum toxin-A, Allergan) therapy. It is not unusual to have to use RESTYLANE^® only once in the glabella if good BOTOX^® therapy is maintained afterward. With regard to the fine perioral lines, it is of vital importance NOT to simply inject the lines since this will lift the surrounding skin, reversing the youthful “ski-jump” projection of the lips. We prefer to enhance the vermilion border and perhaps the lips themselves and to only inject the fine radial rhytids very gently. RESTYLANE^® Touch is designed for this kind of fine work.

Nasolabial Folds

We frequently use a threading technique along the nasolabial fold, concentrating on the upper Y-shaped area below the nares and lateral to the ala. Deepening of this area is related to age-induced loss of fat so correction will produce a more youthful appearance. Because there is less movement in this area close to the nose, correction persists well. The further down the nasolabial fold one is correcting, toward the smile lines beside the oral commissure, the shorter the duration of the correction. In addition, the smile lines are produced by the expression of a positive emotion and so correction of this area may be less of a priority. Discussion of this differential treatment of the nasolabial folds with the subject prior to treatment is very important. Injection is in the mid-to-deep dermis. Where it is available, RESTYLANE^® Perlane is often used for nasolabial fold correction.

Lips

The lips are one of the most important areas for the use of RESTYLANE^® and deserve separate discussion. The aim of lip injection is, in younger individuals, to enhance the size and shape of the lips. In older individuals the aim is more one of correction: to get the lips back to where they were rather than to increase their size. For many patients, the aim is a combination of the two. Injecting lips is more likely to produce adverse events than any other area. In particular, short-term swelling is common and bruising is also seen frequently if good technique is not used. In order to limit this effect, the application of ice or ice packs for 5-20 minutes after injection is favored by some.

Though there is nothing in the literature to support its use at this time, some experienced clinicians provide patients with prednisone 30mg to be taken the morning of the procedure and again the next morning; or 30mg to be taken at bedtime on the day of injection if their lips are swollen, and 30mg to take the following morning if their lips are swollen. Using this technique, minimizes swelling which allows the treated individual to continue with their business and social life rather than having to hide for a day or two. Lip injection is quite uncomfortable. Many use infraorbital and mental nerve blocks to limit discomfort while others prefer distraction techniques such as vibration analgesia.

To limit bruising the needle should be inserted gently through the lip mucosa close to the vermilion and gentle pressure exerted on the plunger. The needle tip can then be advanced using RESTYLANE^® to dissect ahead of the tip, and moving blood vessels out of the way (the “push-ahead” technique). It should be possible to reduce the bruising rate to well below 10% using this technique as well as to avoid the use of NSAIDs, etc.

We use a threading technique on the lips. The needle tip is inserted either just mucosal to the vermilion for vermilion enhancement, or 2-3mm on the mucosa for lip enhancement. Gentle pressure on the plunger should produce flow of the RESTYLANE^® across the lip in the chosen plane ahead of the needle tip. It is essential to continue the injection into the area of the commissure, and above and below the commissure. RESTYLANE^® is our NASHA of choice for lip enhancement.

Contouring

Because of the persistence of NASHA, especially in non-mobile areas, correction of volume loss or enhancement of volume is an increasingly important indication for the use of RESTYLANE^®, as well as Perlane^® and RESTYLANE^®SubQ. Some of the areas where it is used are:

• the temporal eyebrow area to produce a lateral eyebrow lift
• the nasojugal fold to soften the hollows under the eyes (inject just above the periosteum)
• the zygomatic area to enhance the cheekbone
• the infraorbital hollowing to correct age-related fat loss
• the sides of the chin to correct fat loss and to soften the jowls
• the tip of the chin to augment the mentum.

RESTYLANE^® is injected deep into these areas with no attempt at dermal injection. We will frequently use a 30 gauge 1″ needle, or an even longer needle in order to fan the material deep in the subcutis and then massage aggressively in order to avoid lumpiness. Bruising is a risk when injecting at this level because of the larger vessels so using the “push ahead” technique described under Lips described above will be helpful.

Conclusion

NASHA fillers are very effective. RESTYLANE^® lasts twice as long as collagen, no allergy testing is required, and it has an excellent safety profile. Results, however, are highly technique-dependent. The treating physicians must select the subjects and the type of wrinkle or crease carefully, with experience they can become highly skilled in the use of this filler.

References

1. Andre P. Evaluation of the safety of a non-animal stabilized hyaluronic acid (NASHA – Q Medical, Sweden) in European countries: a retrospective study from 1997 to 2001. J Eur Acad Dermatol Venereol 18(4):422-5 (2004 Jul).
2. Narins RS, Brandt F, Leyden J, Lorenc ZP, Rubin M, Smith S. A randomized, double-blind, multicenter comparison of the efficacy and tolerability of Restylane versus Zyplast for the correction of nasolabial folds. Dermatol Surg 29(6):588-95 (2003 Jun).
3. Carruthers J, Carruthers A. A prospective, randomized, parallel group study analyzing the effect of BTX-A (Botox) and nonanimal sourced hyaluronic acid (NASHA, Restylane) in combination compared with NASHA (Restylane) alone in severe glabellar rhytids in adult female subjects: treatment of severe glabellar rhytids with a hyaluronic acid derivative compared with the derivative and BTX-A. Dermatol Surg 29(8):802-9 (2003 Aug).

¹Section of Cutaneous and Aesthetic Surgery, Department of Dermatology, Northwestern University, Chicago, IL, USA
²SkinCare Physicians, Chestnut Hill, MA, USA
³Department of Medicine (Dermatology), Dartmouth Medical School, Hanover, NH, USA
⁴Section of Dermatologic Surgery and Cutaneous Oncology, Department of Dermatology, Yale University School of Medicine, New Haven, CT, USA

ABSTRACT

Photodynamic therapy (PDT) has been used for several years for the treatment of actinic keratoses and prevention of invasive nonmelanoma cancers. More recently, increasing physician expertise with the topical sensitizers and light sources employed in PDT has led to expanded applications, including its use for improvement of the visible signs of photoaging. Aesthetic treatment of photoaged skin with brief application of topical 5-aminolevulinic acid followed by well-tolerated light sources, such as intense pulsed light or pulsed-dye laser, can enhance the effectiveness of nonablative laser treatment without increasing adverse effects or downtime.

Key Words: photodynamic therapy, intense pulsed light, pulsed-dye laser, aminolevulinic acid, photoaging

Nonablative laser and light sources have been widely used for the reduction of the visible signs of photoaging for several years. The benefits of nonablative treatment include quicker patient recovery time due to the absence of marked postoperative erythema, desquamation, and crusting. Moreover, the risks of unwanted pigmentary and textural abnormalities are much reduced in nonablative rejuvenation compared to ablative treatment.

The benefits of nonablative treatment are partially counterbalanced by its reduced efficacy relative to laser skin resurfacing. Among the novel methods for maximizing the efficacy of nonablative treatment is the concurrent use of a photosensitizing agent, such as 5-aminolevulinic acid (5-ALA).¹

5-ALA and Light: Well-Tolerated Treatment of Actinic Keratoses and Photoaging

Originally developed to be used with red or blue light to treat superficial cutaneous malignancies and premalignant lesions (e.g., actinic keratoses), 5-ALA has recently been applied in combination with a variety of light sources, such as pulsed-dye laser and intense pulsed light, to increase the effectiveness of light treatment. This cosmetic use entails less intense 5-ALA pretreatment regimens and more well-tolerated light doses for activating the photosensitizer.

This so-called “photodynamic photorejuvenation” was discussed in the literature as early as 2002, when Ruiz-Rodriguez and colleagues² treated 17 patients with a combination of actinic keratoses (AKs) and diffuse photodamage. They applied 20% 5-ALA mixed in an oil-in-water emulsion and under occlusion for 4 hours prior to treatment (0.2g/cm2) with the pulsed light device (Epilight®, Lumenis), using a 615nm cutoff filter, total fluence of 40J/cm2 in double pulse mode of 4.0msec with 20msec interpulse delay. Approximately 3/4 of the AKs and adjacent photodamaged skin resolved 1 month after the first treatments, and posttreatment erythema, edema, and crusting lasted up to 10 days.

These results were extended by Alexiades-Armenakas and Geronemus,³ who showed that photodynamic treatment of AKs could be accomplished gently, not only with intense pulsed light (IPL), but also with 595nm pulsed-dye laser (PDL) (Vbeam®, Candela). The PDL offered the benefits of rapidity of treatment as well as the comfort and protective epidermal effects associated with cryogen spray cooling. The 5-ALA incubation times were as brief as 3 hours and nonpurpuric PDL settings (4-7.5J/cm2, pulse duration of 10ms, 10mm spot size, and 30ms cryogen spray with 30ms delay) were used. Minimal intraoperative stinging, burning, and pain were reported, and while there was some postoperative erythema, no purpura, crusting, or scarring was seen. While Alexiades-Armenakas and Geronemus were focused on the treatment of AKs, they demonstrated that laser and 5-ALA could be effectively used with virtually no downtime.

5-ALA and Light:  Treatment of Photoaging Alone

Indeed, anecdotal use of IPL and PDL for improvement of the visible signs of aging has rapidly spread. Now the first discrete studies of this application are becoming available. Avram and Goldman⁴ retrospectively reviewed 17 patients treated with 5-ALA and IPL and found 55% improvement in telangiectasia, 48% improvement in pigmentary abnormalities, and 25% improvement in coarseness of skin texture, but minimal change in fine wrinkles. Low doses of 5-ALA and IPL permitted post-operative courses significant for only mild erythema and edema for 3-5 days. Separate preliminary studies by both Gold⁵ and Roe, et al.⁶ have also indicated treatment efficacy following short contact (30-60 minutes incubation) full-face incubation with 20% 5-ALA followed by treatment with IPL.

Recently, a prospective, randomized, controlled trial comparing efficacy and tolerability of 5-ALA followed by IPL treatment with IPL alone was performed by Dover, Bhatia, and Arndt (unpublished data, October 2004).  A total of three split-face treatments were delivered to each of 20 patients, and these were followed by two whole-face IPL-only treatments, also 3 weeks apart. Prior to each of the first three treatments, one side of each patient’s face was precleansed with acetone and received topical 5-ALA solution for 45 minutes (+15 minutes). The 5-ALA solution was washed off before treatment was commenced with a 560-1200nm device (IPL™ Quantum SR, Lumenis Inc.) using the standard SR head on Program 1 (first pulse of 2.4ms, second pulse of 4.0ms, 14ms interpulse delay; fluence of 23-28J/cm2; epidermal cooling chiller tip on maximum). After each treatment, patients again washed their faces and applied a moisturizer containing an SPF 30 sunscreen. Assessment of outcomes was conducted using a comprehensive rating measure that evaluated global photodamage, fine lines, mottled pigmentation, tactile roughness, and sallowness, each on a 0-4 scale; measurements were obtained by a blinded rater before treatment and 4 weeks after the final treatment. The 5-ALA-IPL sides were associated with 80%-95% improvement on the various subscales compared to 20%-55% improvement for the 5-ALA-only sides. The greatest relative improvements in the 5-ALA-IPL sides were in mottled hyperpigmentation and global photoaging, and to a lesser extent, in fine lines. Tactile roughness and sallowness did not appear to show greater improvement with 5-ALA-IPL treatment vs. IPL alone. Not only the independent rater, but also patients preferred the benefits of the combined 5-ALA-IPL treatment. Significantly, side-effects and tolerability did not differ between the IPL-only treated areas and the areas treated with 5-ALA-IPL.

General Treatment Guidelines

1. IPL (and other light sources, including PDL) can be used after pretreatment with 5-ALA to reduce the visible signs of photoaging.
2. Patients should be instructed that red/brown dyspigmentation and overall appearance are likely to improve significantly, and fine lines, to a lesser extent.
3. Pretreatment with acetone or alcohol is followed by short contact (approximately 1 hour) application of 20% 5-ALA. This is then thoroughly washed off before IPL treatment.
4. IPL or PDL treatment should be delivered at standard parameters.
5. After treatment, the treated area should again be washed off, and moisturizer and sunscreen applied.
6. Patients should be instructed to practice strict sun avoidance and sun protection for the remainder of the treatment day and the next day.
7. Additional treatments are delivered at 3-4 week intervals, with a standard regimen consisting of 3-6 treatments. While it appears from the Dover study that three combined 5-ALA-IPL treatments may produce results as good as or better than five IPL alone treatments, further study is necessary to confirm this finding.

Management of Undesired Effects6

The 5-ALA-IPL or PDL treatment for photoaging is a safe treatment associated with patient comfort during treatment and rapid, uneventful recovery after treatment. There are two potential problems that can be easily detected and treated. Phototoxicity occurs when patients disregard instructions regarding post-treatment sun avoidance. The best treatment is prevention, including strict sun avoidance for 24 hours after treatment. If phototoxicity does occur, it presents as well-demarcated erythema and edema at the treated sites. Application of ice and topical corticosteroid ointments, rest, and the passing of time will aid in resolution of symptoms. The risk of superficial infection is very low. Patients with a history of recurrent cold sores may be given antiviral prophylaxis for herpes simplex prior to treatment. Superficial bacterial infections or impetigo may occur at extremely sun-damaged sites or at locations where the 5-ALA solution has not been completely washed off before IPL treatment. These are typically easily treated with topical antibiotics, such as mupirocin.

Conclusion

Topical 5-ALA enhances the efficacy of laser and light treatment of facial photoaging. While IPL devices have been used most often in this combination therapy, other lasers and light sources, including PDL, appear effective as well. Moreover, combination 5-ALA and light therapy does not add to recovery time or discomfort. Provided sun avoidance is practiced for a day following treatment, combination therapy, like laser or light alone, is associated with mild posttreatment erythema and edema, but no crusting or erosions. The new short-contact regimens of 5-ALA require pretreatment for 30-60 minutes, no longer than the duration of applications of topical anesthetics used for various cutaneous procedures. Finally, prepackaged 20% 5-ALA (Levulan® Kerastick®, DUSA Pharmaceuticals) does not require time-consuming preparation prior to application. In short, 5-ALA-light therapy is a further refinement of nonablative laser therapy that permits effective treatment of photoaging with minimization of post-treatment effects.

References

1. Alam M, Dover JS, Arndt KA. Energy delivery devices for cutaneous remodeling: lasers, lights, and radio waves. Arch Dermatol 139(10):1351-60 (2003 Oct).
2. Ruiz-Rodriguez R, Sanz-Sanchez T, Cordoba S. Photodynamic photorejuvenation. Dermatol Surg 28(8):742-4 (2002 Aug).
3. Alexiades-Armenakas MR, Geronemus RG. Laser-mediated photodynamic therapy of actinic keratoses. Arch Dermatol 139(10):1313-20 (2003 Oct).
4. Avram DK, Goldman MP. Effectiveness and safety of ALA-IPL in treating actinic keratoses and photodamage. J Drugs Dermatol 3(1 Suppl):S36-9 (2004 Jan-Feb). 
5. Gold MH, Goldman MP. 5-aminolevulinic acid photodynamic therapy: where we have been and where we are going. Dermatol Surg 30(8):1077-83 (2004 Aug).
6. Rao J, Goldman MP, Gold MH. ALA-PDT photorejuvenation. In: Goldman MP, ed. ALA Photodynamic Therapy. In: Dover JS, Alam M, series ed. Procedures in Cosmetic Dermatology. London: Elsevier; 2005.

¹Section of Cutaneous and Aesthetic Surgery, Department of Dermatology, Northwestern University, Chicago, IL
²SkinCare Physicians, Chestnut Hill, MA
³Department of Medicine (Dermatology), Dartmouth Medical School, Hanover, NH
⁴Section of Dermatologic Surgery and Cutaneous Oncology, Department of Dermatology, Yale University School of Medicine, New Haven, CT

ABSTRACT

Nonablative laser and light therapy is a relatively novel modality for the improvement of the visual appearance of photodamaged, scarred, and injured skin. A number of different wavelengths and devices have been purported to be efficacious for the delivery of nonablative therapy. Among the features that can be addressed are red spots and telangiectasia, pigmentation and lentigines, and fine rhytides. A major attraction of nonablative therapy is the very limited downtime after each treatment. Patients can continue their daily routines while benefiting from the cumulative effects of skin rejuvenation.

Key Words: photodamage, nonablative therapy

What is Nonablative Laser and Light Therapy?

Nonablative laser and light treatments (other equivalent terms include subsurface resurfacing, photorejuvenation, and laser toning) have been used for several years for the aesthetic improvement of photoaged skin, particularly of the face. These treatments provide an alternative to traditional full-face laser resurfacing, an ablative modality in which carbon dioxide and/or erbium:YAG lasers are used to remove the entire epidermis and portions of the dermis. Ablative resurfacing improves skin roughness, fine and moderately deep facial wrinkles, and dyspigmentation by replacing the damaged epidermis and superficial dermis with a new papillary dermis and overlying epidermis. While results in expert hands are impressive, patients undergo an unpleasant healing period of 1-2 weeks during which time there is swelling, oozing and crusting, as well as discomfort. All nonablative treatments improve skin texture and tone, some improve wrinkles or surface irregularities including scarring, and some additionally address dyspigmentation and/or erythema and telangiectasia. The epidermis is not visibly disrupted in nonablative treatment. Nonablative resurfacing is attractive to physicians and patients alike because, contrary to ablative resurfacing, there is little if any downtime.

What are the Available Nonablative Devices?

Based on the work of Zelickson and Kilmer¹ the pulsed dye laser was initially found to induce dermal fibroblasts to produce a zone of new collagen within the papillary dermis after one or two purpuric treatments to photoaged periocular skin. Since then it has been determined that a significant number of wavelengths of both visible and infrared radiation applied to the skin have the ability to induce this very same change. It remains to be determined which of the different wavelengths is most effective at inducing this change.

Numerous laser and light devices,² including the KTP laser (532nm), pulsed dye laser (585nm, 595nm), intense pulsed light (IPL) devices (515-1200nm), Nd:YAG lasers (1064nm Q-switched, 1064nm long-pulse, 1319nm, 1320nm), diode lasers (980nm, 1450nm), Er:Glass laser (1540nm) and light emitting diodes have been adapted to be effective in, or specifically developed for, nonablative resurfacing. The mid-infrared devices, including 1320, 1450, and 1540nm devices, appear most effective for wrinkle and acne scar reduction. Red color and vascular lesions are best addressed by vascular-selective devices, such as the KTP, pulsed-dye, and long pulsed Nd:YAG lasers. The KTP also has efficacy for pigmentation as does the Q-switched Nd:YAG laser, but IPL devices, by virtue of their broad emission spectrum, appear the most effective for simultaneous treatment of both red and brown patches.

Clinical Efficacy: Does Nonablative Therapy Work

Clinical evaluations of this therapeutic intervention have routinely relied on patient and treating physician evaluations and before and after photographs. To assure some degree of standardization in the evaluation process, images have been rated by double-blinded observers, and these ratings supplemented by more objective noninvasive texture measurement such as profilometry, ultrasound, and the PRIMOS (Phaseshift Rapid In-Vivo Measurement of Skin, GF Mestechnik, Teltow, Germany) 3-dimensional in vivo skin imaging system.³ Differences between before and after results can be subtle and not always seen easily, even in side-by-side photographic comparisons. However, the popularity of these treatments among patients and physicians strongly suggests that differences, while not always easy to quantify, are likely real.

Tissue Effects: How and Where Does Nonablative Therapy Work?

For nonablative therapy, an epidermal surface temperature of 40-48º C is ideal since this correlates with a dermal temperature of 55 to 65º C, which is required for collagen denaturation. Recently, there has been some attempt to define the mechanisms underlying the clinical results observed with nonablative resurfacing. Most invasive investigations of nonablative resurfacing have compared the histology of preoperative and postoperative biopsies. A very few investigators have employed in situ hybridization to dissect what is occurring at the mRNA level; however, this work has been limited in scope. In histologic analyses, dermal thickening interpreted as “increased” and “organized” horizontally arrayed bundles of normal collagen fibers in the papillary dermis may in fact be a vestige of trauma and inflammation caused during remodeling after thermal or light injury to the dermis.⁴ Whether the alterations produced by nonablative laser are as persistent as typical photodamage, and the extent to which they are comparable to photodamage, is not known. However, the lasers used for nonablative resurfacing do not emit at ultraviolet wavelengths, and at present there is no evidence to indicate that nonablative laser treatments are deleterious.

Patient Selection and Education

Deciding which patients are best suited for nonablative rejuvenation depends in part on understanding what they want so that it can be determined if nonablative therapy is likely to provide these results. Good candidates for nonablative resurfacing tend to be relatively young, usually 25-65 years of age, and have minimal sagging of the face. Patients should understand that skin texture will improve and fine lines in particular will be softened, not eradicated. Cumulative aesthetic benefits from nonablative resurfacing are similar in type though less in magnitude than the results of ablative resurfacing. Additionally, since changes will occur gradually, typically after three to six or more treatments, those receiving nonablative treatments should not expect dramatic results immediately.

Patients who want to minimize treatment discomfort and downtime tend to appreciate nonablative treatments. These treatments are variably painful. The infrared sources are the most painful of these non-ablative procedures and usually require topical anesthesia for the procedures to be tolerable. Mild erythema and edema do occur following each treatment, but these sequelae remit within minutes to a few hours or may be concealed with cosmetics. Intense treatments can elicit moderate erythema and edema, which may peak 1-2 days after treatment and tend to subside a day or two later. In general, it is important to distinguish between the infrared nonablative devices (1320nm, 1450nm, 1540nm) on the one hand, and pulsed dye lasers, IPLs, and 532 and 1064nm Nd:YAG lasers on the other. Infrared lasers, while uncomfortable, are associated with only a few hours of redness and swelling, while side-effects and longer duration tissue effects are routine with the other devices.

Dark-skinned patients or those with a tendency to develop hyperpigmentation after skin injury can often safely undergo nonablative infrared therapy. These lasers are less prone to pigmentary complications, and patient skin color is less important when using these. With the non-infrared devices, treating tan patients is more risky, and skin color problems after treatment, more likely. Although recent evidence indicates that, in most cases, dark-skinned and Asian patients seldom develop pigmentary abnormalities after nonablative treatment, the risk of hyperpigmentation and hypopigmentation in such patients is still greater than in lighter-skinned patients.

After nonablative treatment, little if any post treatment care is required. Unusually stringent sun protection is not necessary after nonablative therapy although patients should refrain from active sun-seeking behaviors for a few days thereafter. Patients who prefer to continue to receive maintenance therapy for the texture and color of their facial skin will often be satisfied with nonablative resurfacing. After the standard course of three to six nonablative facial treatments separated by 3-4 week intervals, treatments can be continued indefinitely on a 3 to 4 times/year basis. Some patients may choose to receive subsequent treatment courses on different devices to obtain cumulative benefits.

Lasers and light sources should be chosen so that the features most bothersome to the patient are best addressed. Most devices are relatively specific, in that they are better for some purposes.

1. Wrinkle or acne scars are best treated with midinfrared lasers. While acne scarring does not respond very well even to ablative resurfacing, there are some surprising results indicating that nonablative therapy may have significant efficacy for this purpose. There is also evidence to indicate that low energy pulsed dye (NLite) laser can alleviate depressed scars.
2. Red color is best treated with vascular-selective KTP, long pulsed Nd:YAG and pulsed-dye lasers and IPL.
3. Brown color is best treated with pigment-selective KTP, Nd:YAG and Q-switched lasers, and IPL.
4. Texture and color, including red and brown color, can be collectively modestly improved by many different devices. IPL is a particularly effective multipurpose modality, and the infrared lasers are notable in their inability to effectively treat color.

In general, the less specific the patient objective, the greater the likelihood of satisfaction with nonablative therapy. Thus, patients who want removal of a particular feature, like redness or brown spots, or a particular wrinkle, tend to be less pleased after treatment than those interested in overall facial skin rejuvenation. Specific complaints are better treated with a laser device and setting specific for that indication (e.g., a Q-switched laser for lentigines, or a pulsed-dye laser with purpura for a spider angioma).

Specific Features of Nonablative Devices

KTP or frequency-doubled Nd:YAG laser (532nm)
Good for red, brown, texture
The KTP laser has traditionally been used for the treatment of small-caliber focal facial telangiectasia and lentigines. Combined treatment with 532nm KTP and 1064nm Nd:YAG lasers has been shown to provide synergistic benefits.⁵ When used with newer large spot sizes and scanner heads, the 532nm laser can be used to nonablatively resurface the entire face rather than just fine vessels.

Pulsed-dye laser (585nm, 595nm)
Good for red and texture
The pulsed-dye laser, a workhorse in the treatment of facial telangiectasia, diffuse erythema, and other superficial vascular lesions, has also been used with intralesional steroids for the treatment of keloids and hypertrophic scars. Recently, low energy pulsed-dye lasers (e.g., “NLite”), as well as long-pulse pulsed-dye lasers (e.g., pulse durations of 10-40msec) have also been studied. Anecdotal findings have suggested that not only scars, but also minor skin texture irregularities improve after repeated laser applications.⁶ This smoothing effect, coupled with marked reduction in diffuse erythema, may be achievable by multiple treatments with purpura-free, long-pulsed, pulsed-dye lasers. One recent study shows that the low energy pulsed-dye device successfully induces modest improvements in skin texture.⁷ Others have reported efficacy for amelioration of acne scarring as well.⁸

Intense-pulsed light device (500-1200nm)
Good for red, brown and texture
Intense pulsed light devices have been used for the treatment of telangiectasia and erythema, reduction of lentigines, and softening of facial lines and creases. The multiple skin improving functions of intense pulsed light have made it a favorite modality for nonablative therapy. While the degree of improvement of fine lines may be less remarkable, significant simultaneous improvement in brown spots and redness is conducive to overall patient satisfaction. At least five manufacturers now actively market IPL devices in the US, and further research on refining this modality is proceeding briskly.

Nd:YAG laser (1064nm)
Good for brown and texture
The Q-switched Nd:YAG laser was developed for the treatment of skin pigments, including those present in lentigines and tattoos, but has been used by some practitioners for nonablative resurfacing referred to as “ laser toning.” The long pulse 1064nm Nd:YAG laser is primarily a vascular device but has been increasingly used for nonablative treatment.

Mid-infared lasers (1320nm Nd:YAG, 1450nm diode, 1540nm Er:Glass)
Best for texture, wrinkles and texture, Do not help color
This class of lasers has been used to treat periocular and perioral fine rhytides, with the former tending to respond better. They are less effective at treating pigmentation and vascular lesions. The 1450nm laser has also been used for the nonablative treatment of acne via partial necrosis of sebaceous glands. Mid-infrared devices, like the 1064nm Nd:YAG, can induce serious eye damage in patients and operators if adequate eye protection is not used. Pain during treatment is common, and can be somewhat mitigated with topical anesthesia.

Future Directions for Nonablative Therapy

New machines may provide more specific improvements of greater absolute magnitude. As the mechanisms underlying nonablative therapy are better understood, these treatments may be adapted to exploit these biochemical and physical changes.⁹

Also, combined rejuvenation regimens that incorporate nonablative resurfacing will likely be further perfected. Botulinum toxin and soft-tissue augmentation materials are already being used on the upper and lower face, respectively, to improve lines of negative facial expression and hence augment the wrinkle reduction achievable by nonablative therapy. Glycolic acid peels, and other superficial abrasion techniques such as microdermabrasion can buff and exfoliate the epidermis in association with nonablative therapies that thicken the dermal collagen. The overall result, a rosier glow of the skin and a smoother skin texture, will likely be enhanced as materials technology continues to improve.

References

1. Zelickson BD, Kilmer SL, Bernstein E, et al. Pulsed dye laser therapy for sun damaged skin. Lasers Surg Med 25(3):229-36 (1999).
2. Kelly, Kristen M, Majaron B, Nelson S. Nonablative laser and light rejuvenation. The newest approach to photodamaged skin. Arch Facial Plast Surg 3:230-5 (2001).
3. Friedman PM, Skover GR, Payonk G, Kauvar ANB, Geronemus RG. 3D Invivo optical skin imaging for topographical quantitative assessment of nonablative laser technology. Dermatol Surg 28(3):199-204 (2002 Mar).
4. Alam M, Hsu TS, Dover JS, Wrone DA, Arndt KA. Nonablative laser and light treatments: Histology and tissue effects. Lasers Surg Med, in press.
5. Lee MW. Combination visible and infrared lasers for skin rejuvenation. Semin Cutan Med Surg 21(4)::288-300 (2002 Dec).
6. Bjerring P, Clement M, Heickendorff L, Egevist H, Kiernan M. Selective non-ablative wrinkle reduction by laser. J Cutan Laser Ther 2(1):9-15 (2000 Mar).
7. Rostan E, Bowes LE, Iyer S, Fitzpatrick RE. A double-blind, side-by-side comparison study of low fluence long pulse dye laser to coolant treatment for wrinkling of the cheeks. J Cosmet Laser Ther 3(3):129-36 (2001 Sep).
8. Patel N, Clement M. Selective nonablative treatment of acne scarring with 585 nm flashlamp pulsed dye laser. Dermatol Surg 28(10):942-5 (2002 Oct).
9. Ross EV, Zelickson BDK. Biophysics of nonablative dermal remodeling. Semin Cutan Med Surg 21(4):251-65 (2002 Dec).

ABSTRACT

Traditionally, dermatologic surgeons have referred women seeking breast reduction to plastic surgeons for excisional mammoplasty. However, with recent advances in small cannula tumescent liposuction surgery, referral for such surgery may be unnecessary in some cases. Breast liposuction can reduce the size of female breasts that have essentially normal architecture with a minimum of visible scarring and an aesthetically pleasing result. We describe a method for liposuction reduction of female breasts that is safe, efficacious, and associated with high levels of patient satisfaction. Liposuction for breast reduction in women is an appropriate addition to the array of liposuction procedures available to the dermatologic surgeon.

Key Words:
liposuction, breast reduction

A Brief History of Liposuction

Liposuction is the aesthetic removal of undesirable localized collections of subcutaneous adipose tissue. The procedure was developed in the mid-1970’s by Georgio and Arpard Fischer and advanced with innovative suctioning equipment created by Yves-Gerard Illouz. The technique of tumescent anesthesia introduced by Jeffrey Klein in 1987, significantly improved safety while reducing the complications associated with the procedure. Refinement of liposuction methods has enabled physicians to treat challenging areas such as arms, inner thighs, neck and jowls and more recently the female breast.

Breast Reduction Strategies

Breast reduction by liposuction includes several approaches. Traditional breast reduction surgery may be preceded or followed by moderate volume liposuction. Adjunctive use of liposuction can be useful for thinning pedicles, removing axillary and lateral chest wall fat, contouring the inframammary fold, and adjusting volume to correct asymmetries after conventional bilateral reduction mammoplasty. Alternatively, modest breast hypertrophies can be initially treated by liposuction, with the extent of further excisional mammoplasty dictated by the quantity of residual tissue. This approach is also used to treat congenital asymmetry in adolescents and to correct pseudoptosis. During the last decade, liposuction alone has been used for reducing mild gynecomastia that entails excess breast fatty tissue but near-normal glandular breast tissue. In 1991, Alan Matarasso and Eugene Courtiss^1,2 reported that liposuction alone could reduce each treated breast by 75-475cc in patients aged 18 to 60. One to five-year follow-up found no fat reaccumulation or breast reenlargement.

Advantages of Breast Reduction by Liposuction

Breast liposuction can give dramatic results and offer significant advantages over surgical reduction. Unlike traditional approaches, breast liposuction does not require glandular resection and movement of the nippleareola complex on a local pedicle. Thus, the inverted Tshaped scar is avoided, and scars after lipectomy are virtually undetectable if the inframammary/axillary line approach is used. Since there is no cutting of breast tissue, more vessels, nerves, parenchyma and supporting connective tissue are left intact so there is minimal disturbance to sensation and lactation. From the standpoint of the surgeon, no pedicle, flap or dissection is required, and no parenchymal structures are transected. There is a consequent dramatic decrease in reported complications with liposuction alone compared to excisional breast reduction, which can in as many as 50- 60% of patients induce infection, bleeding, hematoma, seroma, wound dehiscence, skin necrosis, hypertrophic scars or keloids, poor breast shape, loss or alteration of sensation, or inability to breast-feed. Since liposuction is a minimally invasive outpatient procedure performed under local anesthesia, postoperative wound care is minimal and recovery time is brief. Maintenance of the architecture of the breast, including neurologic, vascular, and glandular structures, results in preservation of sensation and symmetry.

Is Breast Liposuction Safe?

Critics of liposuction for breast reduction have raised the possibility of interference with mammography.³ Potential problems after liposuction have been proposed to include septal distortion from scarring, increased breast density due to selective extraction of fat, and extensive fat necrosis culminating in microcalcification. While post-liposuction mammograms demonstrate greater tissue density and an increase of parenchymal microcalcification, these postliposuction calcifications are easily and reliably distinguished from malignant calcifications, which are less scattered, less regular, and more numerous.^3,4 To further protect the patient, before liposuction, a preoperative mammogram should be obtained. Within six months postoperatively, a repeat study should be done to detect changes due to liposuction alone.

Who Should Get Breast Liposuction?

Certain criteria must be met for successful breast liposuction:^1,2

• The patient’s skin tone must be sufficiently elastic for shrinkage to the post-operative contour. Patients with so-called “soft (non-elastic) skin” should be advised that they may be less than ideal candidates for breast reduction with liposuction alone.
• The nipple-areola complex must be well-located and the relationship of the nipple to the inframammary crease satisfactory. Satisfactory nipple position is an anterior orientation that is not inferiorly deviated or ptotic. Liposuction alone cannot correct nipple ptosis, reduce the size of the nipple-areola complex, or relocate the complex. Women with mild breast ptosis may experience mild to moderate post-operative improvement in ptosis. However, the definitive treatment for ptosis remains cold steel breast reduction surgery.
• The density of the breast must be appropriate. Treatable breast enlargement must be largely due to fatty tissue rather than excess glandular parenchyma, which is less amenable to liposuction.

Breast liposuction can provide a diminution of breast size of one to two cup sizes. Patients desirous of greater reduction should be counseled to consider excisional mammoplasty. Before breast liposuction, patients should receive a baseline mammogram. Anticoagulants and antiplatelet agents, such as vitamin E supplements and daily aspirin, should be discontinued a week in advance of the procedure in consultation with the patient’s primary care physician.

How is Breast Liposuction Performed?

Preoperative measurement of breast weight utilizing a digital scale and volumetric measurement using water displacement can help the surgeon decide how much fat to remove and how the total should be distributed between the two breasts to ensure an even result. Multiple, usually two, stab incisions are made in the inframammary crease of each breast with a third incision placed in the anterior axillary line. Tumescent anesthesia is then infused per customary technique.^5-6 Infusion is performed throughout the entire breast as well as parallel to the plane of the chest wall. Approximately 600-800cc of tumescent solution is typically required to fill each breast and ensure that the deep portion of the breast adjacent to the chest wall is completely infiltrated. Thirty to forty-five minutes after tumescent infusion is complete, liposuction is initiated with appropriate cannulas, such as the 12-gauge Klein and 12- gauge Capistrano cannulas. Machine suction is performed via standard criss-cross triangulating technique, with fanning from each of the entry sites. Like tumescent fluid infusion, suction is best performed throughout the entire volume of the breast. It is essential that the surgeon continuously palpate and monitor breast size and symmetry during breast liposuction. The non-dominant hand is used to pinch and assess breast volume and contour as liposuction progresses. Superficial suctioning should be avoided, as should aggressive suctioning under the nipple complex. This process of conservatism and continual reevaluation increases the likelihood that breast symmetry and contour is maintained postoperatively. Additionally, many women benefit significantly from thorough, even fat removal from the lower outer quadrant of the breast. Treatment of this area can aid in volume reduction as well as skin retraction and mild breast elevation.

Results and Aftercare

Suction volumes vary, with 250-500cc of fat typically removed from each breast. At the conclusion of suctioning, the surgeon can readily confirm breast size and symmetry by palpating the breast to estimate the residual volume, as well as by comparing volumes of fat removed from each breast during the procedure. Use of a compression binder or support bra after surgery is essential. Continuous use of such a device for the first three months after surgery ensures maximum smoothness and uniformity of the final contour. The initial postoperative compression garment is worn 23 hours/day for the first 7 days, followed by the use of a properly fitted support bra 16-24 hours a day for the next 3 months. More so than with liposuction of other anatomic areas, the cosmetic end result is highly dependent on patient adherence to a strict regimen of garment use, and patients should be apprised of their vital role in this process.

Conclusion

Liposuction for breast reduction in women is an appropriate addition to the array of liposuction procedures available to the dermatologic surgeon. Minimally invasive and sparing of the breast parenchyma, breast liposuction has an excellent safety profile and rapid recovery time. Cosmetically elegant, it provides symmetrical results with barely visible scarring. Minor reductions in breast size in patients with normal shaped breasts will look better after liposuction alone than any other type of breast reduction surgery. Patients requiring change in the overall shape or orientation of the breasts and nipples, elderly patients, and patients requiring highvolume breast reduction should be referred to our plastic surgery colleagues for excisional procedures.⁷

References

1. Baker TM. Suction mammoplasty: The use of suction lipectomy to reduce large breasts. Plast Reconstr Surg 106(1):227 (2000 Jul).
2. Matarasso A, Courtiss EH. Suction mammoplasty: The use of suction lipectomy to reduce large breasts. Plast Reconstr Surg 87(4):709-17 (1991 Apr).
3. Robertson JL. Changed appearance of mammograms following breast reduction. Plast Reconstr Surg 59(3):347-51 (1977 Mar).
4. Abboud M, Vadoud-Seyedi J, De Mey A, Cukierfajn M, Lejour M. Incidence of calcifications in the breast after surgical reduction and liposuction. Plast Reconstr Surg :96:620-626(1995).
5. Klein JA. Tumescent Technique: Tumescent Anesthesia and Microcannular Liposuction. St. Louis MO: Mosby (2000).
6. Hanke CW, Coleman WP 3rd, Lillis PJ, et al. Infusion rates and levels of premedication in tumescent liposuction. Dermatol Surg 23(12):1131-4 (1997 Dec).
7. Hidalgo DA, Elliot LF, Palumbo S, Casas L, Hammond D. Current trends in breast reduction. Plast Reconstr Surg 104(3):806-15 (1999 Sep).

Industry News

FDA Strengthens Controls and Issues Consumer Alert on Importing Certain Prescription Drugs

As part of its ongoing efforts to reduce preventable adverse events from the products it regulates, the US Food and Drug Administration (US FDA) announced in December 2002, that it is strengthening the controls designed to protect patients by restricting imports of certain prescription drugs that can be used safely only with specified controls in place.

The FDAs action involves adding these drugs to an existing FDA Import Alert, which alerts FDA field personnel to the possible importation of these drugs, provides guidance as to their detention and refusal of admission into the United States. It also advises US Customs personnel to refer any attempted importation to the local FDA field office.

The drugs added to the Import Alert are as follows:

• Accutane® (isotretinoin) – indicated for the treatment of severe recalcitrant nodular acne
• Actiq® (fentanyl citrate) – indicated for the management of severe cancer pain in patients who are tolerant to opioid therapy
• Clozaril® (clozapine) – indicated for the management of severe schizophrenia in patients who fail to respond to standard drug treatments for schizophrenia
• Lotronex® (alosetron hydrochloride) – indicated for the treatment of severe irritable bowel syndrome in women
• Mifiprex® (mifepristone or RU-486) – indicated for the medical termination of early intrauterine pregnancy
• Thalomid® (thalidomide) – indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum
• Tikosyn® (dofetilide) – indicated for the maintenance of normal sinus rhythm in patients with certain cardiac arrhythmias
• Tracleer® (bosentan)- indicated for the treatment of severe pulmonary arterial hypertension
• Trovan® (trovafloxacin mesylate or alatrofloxacin mesylate injection) – an antibiotic administered in in-patient health care settings for the treatment of severe, life-threatening infections
• Xyrem® (sodium oxybate) – indicated for the treatment of cataplexy in patients with narcolepsy

In a related action, the US FDA today alerted consumers not to buy these drugs over the internet, because drugs obtained via websites usually are not accompanied by these safety controls. The FDA is concerned about the safety risks posed by use of any of these products without the specified controls in place.

Although these drugs have important benefits for many patients, they have serious known risks and so are available in the US only under specially created safety controls. These safety controls are bypassed when these drugs are purchased from foreign sources, placing patients who use these imported drugs at higher risk. Therefore, because of this higher risk to patients, the FDA took action to further curtail the products’ availability from foreign sources. The drugs purchased from foreign sources are generally not FDA-approved.

Controls on these prescription drugs include limiting their distribution to specific facilities (such as hospitals); limiting their distribution to physicians with special training or expertise; or requiring certain medical procedures (such as pregnancy testing or blood testing) with their use.

Detailed information for consumers and patients who would like to learn more about how to buy prescription drugs safely may be found in FDAs guide, “Buying prescription Medicines Online: A Consumer Safety Guide,” available online at FDA.gov/cder/drug/consumer/buyonline/guide.htm.

Source: US FDA News Release

Patient Alert

American Academy of Dermatology Stresses the Safe Use of Botulinum Toxin

Since the Food and Drug Administration (FDA) approval of one form of botulinum toxin, it has been widely reported that patients are attending so called “Botox® parties” for the administration of this drug. Botulinum toxin treatments being performed in casual social settings rather than in a controlled medical environment contradicts the seriousness of this medical procedure.

As with any medical procedure, the possibility of adverse effects occurring from a botulinum toxin injection is always a possibility. Adding alcohol to the mix is a bad idea for a number of reasons, especially since bruising can be intensified.

Botulinum toxin is a purified form of one of the most potent toxins in the world. In high doses, it can cause the clinical disease botulism. However, when carefully injected by dermatologists and dermatologic surgeons in very low doses, botulinum toxin is a modern tool that can reduce the signs of aging. The American Academy of Dermatology (AAD) urges patients to select a qualified physician, such as a dermatologist, when considering this or any cosmetic procedure.

Because this is a quick method to treat wrinkles with no downtime, many patients are compromising their safety by having this medical procedure performed in an inappropriate setting, often by untrained medical professionals. To assist patients in choosing a qualified physician, the AAD recommends that before undergoing any cosmetic procedure, patients should ask the following questions:

• What are the doctor’s credentials? Is he/she a board-certified dermatologist or other appropriately trained surgeon? Ask to see their credentials.
• How many of these cosmetic surgery procedures has the physician performed?
• What results can be expected?
• How long is the recuperation period? Ask to see before and after photos of the physician’s previous patients.
• What are the risks?
• Where is the cosmetic surgery usually performed?
• What is the cost?

The AAD encourages all patients to consult with their dermatologist to determine which treatment is best for them. A wellinformed patient and a skilled dermatologist are always the best prescription for a successful outcome.

For more information, contact the AAD at 1-888-462-DERM (3376) or www.aad.org.

Source: AAD News Release