STL Volume 26 Number 5 – Skin Therapy Letter https://www.skintherapyletter.com Written by Dermatologists for Dermatologists Wed, 24 Nov 2021 16:57:49 +0000 en-US hourly 1 https://wordpress.org/?v=6.8.1 Labeling Laws for Personal Care Products: Potential Pitfalls for The Consumer https://www.skintherapyletter.com/dermatology/personal-care-products-labeling/ Fri, 10 Sep 2021 22:15:15 +0000 https://www.skintherapyletter.com/?p=12765 Evelyne Tantry1; Ariadna Perez-Sanchez, MD2; Shelly Fu3; Shravya Potula3; Rajani Katta, MD3,4

1Rice University, Houston, TX, USA
2Department of Internal Medicine, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA
3Baylor College of Medicine, Houston, TX USA
4Department of Dermatology, McGovern Medical School at University of Texas Health Science Center at Houston, Houston, TX, USA

Conflict of interest:
Rajani Katta is author of a book for the general public on dermatology, and is on an advisory board for Vichy Laboratories.
Evelyne Tantry, Ariadna Perez-Sanchez, Shelly Fu, and Shravya Potula have no conflicts of interest to declare.

Abstract:
Consumers of personal care products must be made aware of the potential pitfalls that arise from current labeling practices and regulations. For example, terms such as “hypoallergenic“, “sensitive skin“, and “baby product” lack legal definitions, and terms such as “fragrance-free“ are frequently misinterpreted. Personal care products are a general category that includes such items as cosmetics, drugs, dietary supplements, and consumer goods. This overview of current US FDA regulations of products in this category reviews pertinent regulatory policies and highlights potential consumer pitfalls when evaluating product labels. In particular, current labeling laws permit the use of language that may be incomplete, misinterpreted, or applied solely for marketing purposes. It is important that consumers understand the meaning of labeling terms, the regulations that govern them, and especially understand the potential pitfalls related to these terms.

Key Words:
personal care products, cosmetics, labeling regulations, fragrance-free, hypoallergenic, sensitive skin, baby products

Background

For consumers choosing among the wide variety of personal care products available, an understanding of current labeling laws and regulations is important. Consumers may be interested in choosing products for sensitive skin, searching for products that are suitable for children, or seeking out products that lack specific allergens. Unfortunately, current regulations limit the utility of many labeling terms to effectively inform the consumer, making it imperative that physicians counsel patients on the specifics of these terms. In this paper, we review areas where consumers may find labels confusing. For each area, we highlight potential pitfalls for consumers when choosing personal care products.

“Personal care products” are not defined by law but rather serve as a general category that can consist of cosmetics, drugs, medical devices, dietary supplements and consumer goods based on the nature of intended use.1 Use of such products may result in allergic contact dermatitis (ACD). Data from the North American Contact Dermatitis Group (NACDG), published in 2018, found that of the top 10 allergens identified by patch testing, nine could be found in personal care products.2 This included six fragrance additives and preservatives, two topical antibiotics (neomycin and bacitracin), and one chemical found in hair dyes (p-phenylenediamine). The treatment of ACD centers on allergen avoidance, and thus an understanding of labeling laws and regulations is critical.

As consumers are faced with a multitude of personal care products, physicians can help by educating them on pertinent regulations and labeling laws. It is important consumers recognize that marketing and safety of personal care products is the responsibility of the manufacturer and is not subject to premarket approval from the US Food and Drug Administration (FDA).3 “Cosmetics”, as defined by the FDA, are any articles intended to be applied to the human body for appearance-altering purposes and include moisturizers, shampoos and makeup.3 ‘Soaps’ fall into a separate category when they are mainly composed of “alkali salts of fatty acids,”4 although the product becomes a “cosmetic” if it contains synthetic detergents or is intended to moisturize or deodorize the body.4

The FDA primarily governs cosmetics and other personal care products through the Federal Food, Drug, and Cosmetic Act of 1938 (FDCA) and the Fair Packaging and Labeling Act of 1967 (FPLA).3 With these acts, Congress created broad parameters to enable effective regulation of a burgeoning industry. Since their establishment, however, these mandates have not undergone any substantial reform to accommodate the explosive growth of available personal care products.

Table 1 outlines several pertinent regulatory policies that consumers should be made cognizant of when evaluating personal care products. It is vital that consumers recognize that current labeling laws permit the use of language that may be applied solely for marketing, may be incomplete, or may be misinterpreted. Table 2 provides a brief overview of potential pitfalls for the consumer due to current labeling regulations.

 

Regulatory Concern Current Food and Drug Administration Regulations
Ingredient safety data and documentation
  • Under US law, “cosmetic products and ingredients, other than color additives, do not need FDA approval before they go on the market.”14
  • The FDA does not require cosmetic companies “to share their safety data or file their product formulations with the FDA.”14
  • Participation in the FDA Voluntary Cosmetic Registration Program is voluntary. Companies provide the FDA with the “best estimate of information available about cosmetics products and ingredients, their frequency of use, and businesses engaged in their manufacture and distribution”. This information is used by the FDA, as well as “independent, industry-funded” scientific groups, such as the Cosmetic Ingredient Review (CIR), which assesses and reviews ingredient safety data.15
Toxicological testing
  • “Neither the law nor FDA regulations require specific tests to demonstrate the safety of individual products or ingredients.”3
  • Per the FDA, “manufacturers can use whatever testing is necessary to ensure the safety of their products and ingredients.”3 The nature or quality of testing is not specified.
Product recalls
  • The “FDA is not authorized to order recalls of cosmetics” as the process requires “voluntary actions by manufacturers or distributors to remove from the marketplace products that represent a hazard or gross deception, or that are somehow defective.”3

Table 1: Overview of current FDA regulations of personal care products

 


Labeling Topic Current Limitations of US Food and Drug Administration Regulations Potential Consumer Pitfalls Description
Ingredient listing
  • Per the FDA, products containing fragrance additives that act as a masking agent and are present “at an insignificant level may be considered an incidental ingredient in which case it need not be declared on the label.”16
  • Contrastingly, “certain ingredients may be listed generally as ‘fragrance,’ or ‘perfume,’ without identifying the specific ingredients.”17
  • Ingredient listing is not required for personal care products “distributed solely for professional use, institutional use (such as in schools or the workplace), or as free samples or hotel amenities.”3
  • Institutional products (such as those used in salons), free samples, and hotel amenities do not require product ingredient listing.
  • Specific fragrance additives are not required to be listed.
Uniform ingredient naming
  • Ingredients must be listed by their “common or usual name.”18
  • Ingredient names can be selected from the International Nomenclature of Cosmetic Ingredients (INCI), United States Pharmacopeia (USP), the National Formulary and the Homeopathic Pharmacopeia of the United States, Food Chemical Codex, the Index Medica, the Chemical Abstracts or the British Pharmacopeia.19
  • The same ingredient may be listed on a label under different names depending on the manufacturer.
Warning labels
  • Personal care products are exempt from displaying warning labels if it is considered to be “adequately substantiated” by either “available test data on its ingredients and on similar products” or “testing appropriate in the light of the existing data.”16 There are no federal standards for what qualifies as ‘appropriate’ testing.
  • Many personal care products are exempt from displaying specific warning labels.

Table 2: Potential consumer pitfalls when evaluating product labels


Skin and Hair Care Products

Potential pitfalls for consumers when evaluating skin and hair care product labels can be categorized into three broad categories. These include the potential for confusion with marketing terms, labels that are incomplete, and labels that may be misinterpreted.

Marketing Terms

As many labeling terms lack FDA definitions, they can essentially mean anything a manufacturer decides. The term “hypoallergenic”, for example, is not regulated by law. Therefore, although the term is commonly used in marketing a product, it does not inform consumers about the actual safety of a product.

Similarly, there are no legal standards for qualifying a product as a “baby product.” This may lead to consumer concerns about certain ingredients, as in 2013 when Johnson & Johnson was pressured by consumers to remove formaldehyde and 1,4-dioxane from about 100 of its baby products.5 According to the NACDG, formaldehyde is the fourth most common allergen in cosmetics.2

One study evaluated the use of marketing terms on products. Researchers found that out of 187 cosmetic products, 89% “contained at least 1 contact allergen, 63% 2 or more, and 11% 5 or more” despite being marketed as “hypoallergenic”, “dermatologist recommended/tested”, “fragrance free”, or “paraben free.”6

The lack of regulation involving personal care products marketed and sold as “hypoallergenic”, “baby product”, “natural,” “for sensitive skin”, and other terms is further discussed in Table 3.

 

Term Food and Drug Administration Regulations Potential Consumer Pitfalls
Hypoallergenic
  • In 1978, the US Court of Appeals for the District of Columbia ruled that the “FDA’s regulation defining ‘hypoallergenic’ was invalid.”20
  • As per the FDA, “there are no federal standards or definitions that govern the use of the term ‘hypoallergenic’” and “the term has no real meaning in the marketplace.”20
  • Companies that manufacture products marketed as ‘hypoallergenic,’ ‘safe for sensitive skin,’ ‘non-allergenic’ or ‘allergy tested’ “are not required to submit substantiation of their hypoallergenicity claims to FDA.”20
  • The term ‘hypoallergenic’ is not regulated by law, and thus, simply means whatever a manufacturer chooses.
  • There is no testing requirement necessary to market a product as ‘hypoallergenic.’
Sensitive skin
  • Presently, “there is no federal standard or definition that governs the use of [phrases such as] ‘for sensitive skin.’”17
  • The FDA instead recommends that consumers refer to the ingredient list, which under the FPLA “requires an ingredient declaration on cosmetic products sold at the retail level.”17
  • There is no federal standard for the term ‘sensitive skin,’ which is purely a marketing term.
Baby products
  • There are no laws explicitly defining what constitutes a ‘baby product’ as they are defined broadly as either ‘cosmetics’ or as a ‘medical device’ (if the product is “intended to cure, treat, mitigate or prevent any illness or disease”).21
  • The only explicit regulation of baby products, in general, is the warning against manufacturers advertising that their products can treat, cure, or prevent the risk of Sudden Infant Death Syndrome (SIDS).22
  • There are no legal metrics for what qualifies a product as a ‘baby product.’
  • Any product can be marketed as a ‘baby product’ and depending on its purpose as a cosmetic or drug, will have varying degrees of labeling regulation.
All natural
  • The FDA does not have any formal regulation, definition or discussion of ‘all natural’ products.
  • The Federal Trade Commission (FTC) reports that there have been incidences when “companies pitched their products as ‘all natural’ or ‘100% natural,’ but included synthetic ingredients.”23
  • Four FTC settlements against the aforementioned companies now prohibit manufacturers from “[mis-stating] the extent to which any product contains natural or synthetic components, [making] misleading claims about ingredients or composition, and [making] deceptive representations about environmental or health benefits.”23
  • Companies are required to provide ‘proof ’ of ‘all natural’ claims. The nature of that proof was not specified by either the FTC or the FDA.24
  • Products marketed as ‘natural’ may still contain synthetic ingredients.
  • Per the FTC, products marketed as ‘all natural,’ suggesting 100% natural composition, cannot contain synthetic ingredients. Products with these claims, however, do not undergo premarket verification
  • No federal standards exist for ‘all natural’ substantiation.
Organic
  • Per the United States Department of Agriculture (USDA), the “FDA does not define or regulate the term ‘organic,’ as it applies to cosmetics, body care, or personal care products.” Rather, the term ‘organic’ is regulated by the USDA for agricultural products through its National Organic Program (NOP, 2008).25
  • ‘Organic’ personal care products are subject to the regulation of both the FDA and USDA.25
  • To be eligible for ‘organic’ certification, a personal care product should “contain or [be] made up of agricultural ingredients, and [be able to] meet the USDA/NOP organic production, handling, processing and labeling standards.”25
  • To be eligible for ‘organic’ certification, a personal care product should “contain or [be] made up of agricultural ingredients, and [be able to] meet the USDA/NOP organic production, handling, processing and labeling standards.”25
  • Alternatively, personal care products “may be certified to other, private standards and be marketed to those private standards in the United States. These standards might include foreign organic standards, eco-labels, earth friendly, etc. USDA’s NOP does not regulate these labels.”25
  • The term ‘organic’ is governed by the USDA, rather than the FDA, even as it applies to cosmetics.
  • The USDA is not the only group capable of certifying organic products. Private companies may also certify organic personal care products under ‘private standards.’
  • Imported ‘organic’ products can be certified using foreign standards.

Table 3: Marketing terms and regulations


Incomplete Labels

“Free of” Labels

The growing trend among consumers to purchase “free of ” ingredient cosmetics, as evident by growing sales and market shares of these products, has prompted cosmetic companies to address these factors when marketing their products.7

While these labels are technically correct, they often do not highlight information that patients would find useful. For example, the words “paraben-free” are often highlighted on product labels. However, for those who are prone to ACD, the words “free of methylisothiazolinone” (MI) would be more useful. The NACDG publishes a Significance-Prevalence Index Number (SPIN) ranking, which is a weighted calculation that incorporates both clinical relevance and prevalence of an allergen.2 MI had the highest SPIN rating of all allergens tested. It has been banned by the European Commission from use in leave-on products, although it is still used in the US. By contrast, parabens were ranked 48th and had the lowest prevalence of positivity of any major preservative on the North American market. In 2019, the American Contact Dermatitis Society announced that because “[parabens] are rarely problematic as contact allergens, [parabens] have been designated (non) allergen of the year.”8

“Active” Ingredients Listed Separately From Inactive Ingredients

For consumers with ACD, knowledge of all ingredients found in a product is critical. Thus, consumers must be aware that certain product categories separate active ingredients from inactive ingredients. Consumers choosing sunscreens, eyedrops, and over-the-counter medications must be informed to seek out information on both active and inactive ingredients, as sections are separated in these product categories.

Labels That May Be Misinterpreted

Fragrance additives are one of the top causes of ACD,2 but avoidance can be challenging for patients. While product labels may use the terms “fragrance-free” and “unscented”, these terms are frequently misinterpreted by consumers.

  • Although the term “fragrance-free” might suggest that a product does not contain any fragrance additives, that is not correct. The FDA defines fragrance as “any natural or synthetic substance or substances used solely to impart an odor to a cosmetic product.” According to that definition, if a fragrance additive is used for another function, then it may legally be included in a fragrance-free product.9 Examples are benzyl alcohol, which may be used as a preservative, and rose oil, which may be used as a moisturizing ingredient.
  • Unscented products may contain masking fragrances.

Sunscreens

Sunscreen labels are also a common source of confusion among consumers, including the sun protection factor (SPF) value. The SPF is defined as the ratio of the amount of ultraviolet (UV) energy required to produce erythema on skin protected by sunscreen, to the amount of energy required to produce erythema on unprotected skin. Contrary to popular belief, an increased magnitude of SPF value above SPF 30 offers minimal increase of protection from UV rays. Specifically, SPF 30 shields the skin from 97% of UV rays and SPF 50 shields 98%.10

Importantly, SPF values only specify protection against UVB radiation, responsible for sunburns.11 The SPF value does not provide information on protection from UVA rays, which damage the deeper layers of the skin and contribute to skin cancer.12

Marketing claims on sunscreens are also of significant concern.13 Many commonly used claims are neither approved nor regulated by the FDA, including claims such as “dermatologist recommended.”13 Unregulated claims are rampant among sunscreens and advertisements, and sunscreens with more than six of these claims have been associated with increased popularity among consumers.13

Another area of concern relates to GRASE products (generally recognized as safe and effective). While GRASE ingredients are regulated by the FDA, some sunscreens are sold in the form of products that are not considered GRASE, including powders, wipes, towelettes, and insect repellants.26 These product forms have not been extensively studied for their safety and sun protection efficacy.26

Insect Repellents

Governed by the Environmental Protection Agency (EPA), insect repellents may be required to list active ingredients, but the “EPA does not require a complete declaration of ‘inactive or inert’ ingredients” nor a list of “the identities of inert ingredients on product labels.”27 The label is only required to list the percent composition of inert ingredients.

Furthermore, because only active ingredients require registration for safety and effectiveness, scented inactive ingredients may present concerns for patients with fragrance sensitivity. Case reports documenting insect repellent contact dermatitis have identified various botanical and fragrance chemical ingredients, such as citronellol, lemon oil, eucalyptus oil, and neem oil.28

Hair Dyes

P-paraphenylenediamine (PPDA) is a common allergen, with the latest data placing it as the 10th most frequent allergen in North America.2 Exposure is primarily via permanent hair dyes.

Although hair dyes in retail stores must list this ingredient, consumers face some challenges. First, unlike other products such as sunscreen, active hair dye ingredients are not required to be highlighted on the label. In fact, active ingredients are typically found as just one ingredient in a long list of chemical names. Second, products that are not intended for retail sale are exempt from ingredient declaration. Products used at a hair salon, therefore, may be exempt from providing ingredients.

In terms of product safety, consumers should realize that FDA approval is not required for hair dyes with PPDA. Regulations divide hair dyes into two categories: coal-tar hair dye (CTHD) and plant or mineral sourced hair dye. Although PPDA is not a coal-tar by-product, it falls into this category. Under FDA regulations there is no need for approval for any of the CTHD.29 Even more worrisome, the FDA cannot take action against a CTHD even if “it is or contains a poisonous or deleterious ingredient that may make it harmful to consumers,” as long as the manufacturer includes a caution statement.29 The only exception is for dyes used in eyelash and eyebrow coloring.

Conclusion

Of the 100+ pages of the FDCA, only two pages discuss cosmetics and personal care product safety. In fact, there is a heavy reliance on safety reporting by manufacturers. Current information from the FDA consists of voluntary ingredient and establishment reporting from companies, along with reports of serious adverse events provided by consumers. Recently, however, there have been efforts to amend the FDCA through the introduction of the Safe Cosmetics and Personal Care Products Act of 2019 and the Personal Care Products Safety Act of 2019. The passage of either bill would increase the regulation of cosmetic labeling and allow the FDA to suspend and even recall the sale of products that cause “adverse health reactions.”30,31

Given the current limitations of federal labeling and safety regulations, it is the responsibility of the consumer to be informed of current regulations and to learn how to accurately evaluate and interpret the information found on personal care product labels.

References



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  12. Dale Wilson B, Moon S, Armstrong F. Comprehensive review of ultraviolet radiation and the current status on sunscreens. J Clin Aesthet Dermatol. 2012 Sep;5(9):18-23.

  13. Prado G, Ederle AE, Shahriari SRK, et al. Online sunscreen purchases: impact of product characteristics and marketing claims. Photodermatol Photoimmunol Photomed. 2019 Sep;35(5):339-43.

  14. U.S. Food and Drug Administration. FDA’s testing of cosmetics for arsenic, cadmium, chromium, cobalt, lead, mercury, and nickel content. Nutrition C for FS and A. Content current as of August 24, 2020. Available from: https://www.fda.gov/cosmetics/potential-contaminants-cosmetics/fdas-testingcosmetics-arsenic-cadmium-chromium-cobalt-lead-mercury-and-nickelcontent. Accessed August 15, 2021.

  15. U.S. Food and Drug Administration. Voluntary cosmetic registration program. Content current as of: August 24, 2020. Available from: https://www.fda.gov/cosmetics/voluntary-cosmetic-registration-program. Accessed August 15, 2021.

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  18. U.S. Food and Drug Administration. Cosmetic ingredient names. Nutrition C for FS and A. Published February 4, 2020. Content current as of August 24, 2020. Available from: https://www.fda.gov/cosmetics/cosmetics-labeling/cosmetic-ingredient-names. Accessed August 15, 2021

  19. U.S. Food and Drug Administration. Center for Veterinary Medicine. Program Policy and Procedure Manual. Guide 1240.4030. Supplemental Policies. Ingredient established names. September 10, 1997. Available from: https://www.fda.gov/media/70119/download. Accessed August 15, 2021.

  20. U.S. Food and Drug Administration. “Hypoallergenic” cosmetics. Nutrition C for FS and A. Content current as of: August 24, 2020. Available from: https://www.fda.gov/cosmetics/cosmetics-labeling-claims/hypoallergenic-cosmetics.Accessed August 15, 2021.

  21. U.S. Food and Drug Administration. How to determine if your product is a medical device. Health C for D and R. Content current as of December 16, 2019. Available from: https://www.fda.gov/medical-devices/classify-yourmedical-device/how-determine-if-your-product-medical-device. Accessed August 15, 2021.

  22. U.S. Food and Drug Administration. Information for manufacturers of baby products. Health C for D and R. P Content current as of August 22, 2018. Available from: https://www.fda.gov/medical-devices/baby-productssids-prevention-claims/information-manufacturers-baby-products. Accessed August 15, 2021.

  23. Fair L. Are your “all natural” claims all accurate? Federal Trade Commission. Published April 12, 2016. Available from: https://www.ftc.gov/news-events/blogs/business-blog/2016/04/are-your-all-natural-claims-all-accurate. Accessed August 15, 2021.

  24. Gressin S. Super (un)natural product claims. Consumer information. Federal Trade Commission. Published April 12, 2016. Available from: https://www.consumer.ftc.gov/blog/2016/04/super-unnatural-product-claims. Accessed August 15, 2021.

  25. United Stated Department of Agriculture. Agricultural Marketing Service. National Organic Program. Cosmetics, body care products, and personal care products. April 2008. Available from: https://www.ams.usda.gov/sites/default/files/media/OrganicCosmeticsFactSheet.pdf. Accessed August 15, 2021.

  26. U.S. Food and Drug Administration. FDA advances new proposed regulation to make sure that sunscreens are safe and effective. News release dated February 21, 2019. Content current as of February 21, 2019. Available from:https://www.fda.gov/news-events/press-announcements/fda-advances-newproposed-regulation-make-sure-sunscreens-are-safe-and-effective. Accessed August 15, 2021.

  27. U.S. Food and Drug Administration. Insect repellent-sunscreen drug products for over-the-counter human use; request for information and comments. Federal Register. Published February 22, 2007. Available from: https://www.federalregister.gov/documents/2007/02/22/E7-2890/insect-repellentsunscreen-drug-products-for-over-the-counter-human-use-request-forinformation-and. Accessed August 15, 2021.

  28. Kullberg SA, Warshaw EM. Summertime dermatitis: when the repellent is the culprit, not the bugs! Dermatitis. 2020 Jul/Aug;31(4):e30-e2.

  29. U.S. Food and Drug Administration. Hair dyes. Nutrition C for FS and A. Content current as of: August 24, 2020. Available from: https://www.fda.gov/cosmetics/cosmetic-products/hair-dyes. Accessed August 15, 2021.

  30. Schakowsky JD. Text – H.R.4296 – 116th Congress (2019-2020): Safe Cosmetics and Personal Care Products Act of 2019. Introduced in House September 12, 2019. Available from: https://www.congress.gov/bill/116th-congress/housebill/4296/text. Accessed August 15, 2021.

  31. Feinstein D. Text – S.726 – 116th Congress (2019-2020): Personal Care Products Safety Act. Introduced in Senate March 7, 2019. Available from: https://www.congress.gov/bill/116th-congress/senate-bill/726/text. Accessed August 15, 2021.


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Hair Removal Practices: A Literature Review https://www.skintherapyletter.com/dermatology/hair-removal-practices/ Fri, 10 Sep 2021 20:12:56 +0000 https://www.skintherapyletter.com/?p=12767 Cindy Na-Young Kang, BMSc1; Monica Shah, MD1; Charles Lynde, MD, FRCPC2,3; Patrick Fleming, MD, MSc, FRCPC2,3

1Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada
2Lynde Institute for Dermatology (Private Practice), Markham, ON, Canada
3Division of Dermatology, University of Toronto, ON, Canada

Erratum


Since the publication of the article “Hair removal practices: a literature review” by Kang CN, Shah M, Lynde C, Fleming P. Skin Therapy Lett. 2021 Sep-Oct;26(5):7-11, the authors have identified current literature that warrants changes to the information presented on the use of lasers and intense pulsed light for hair removal. Electrolysis is noted as the only permanent method of hair removal and that lasers are a temporary hair removal practice (Abstract, in the paragraph under Lasers, in the paragraph under Electrolysis, Table 1 under Lasers Permanency, and Conclusion). However, laser hair removal can in fact be permanent in some individuals especially with longer treatments, as noted in a recent article by Altunel CT, Kartal SP. Reconceptualizing the permanence of alexandrite laser hair removal results: a long-term follow-up study. J Cosmet Laser Ther. 2020 Nov 16;22(6-8):271-4. doi: 10.1080/14764172.2021.1936067. Epub 2021 Jun 5. PMID: 34096438. Table 1 also states that lasers are “effective for thin vellus hairs, and white, grey, or red hairs” under Advantages but this should state lasers are “ineffective for thin vellus hairs, and white, grey, or red hairs” under Disadvantages, as stated in the paragraph under Lasers. Additionally, the efficacy of intense pulsed light for hair removal has been modified in Table 1 and in the 2nd paragraph under the section Intense Pulsed Light (IPL) System. IPL is less expensive than laser hair removal, however, is not as effective, as noted in a recent article by Vaidya T, Hohman MH, Kumar DD. Laser hair removal. [Updated 2021 Aug 26]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2021 Jan. Moreover, although treatment duration may be shorter, IPL typically requires more treatment sessions to produce results.


The authors apologize for any inconvenience caused. The online and PDF version of this article has been corrected.


Funding Sources: None

Conflict of interest:
Cindy Kang and Monica Shah have no conflicts of interest to disclose. Charles Lynde has acted as a principal investigator, speaker and/or consultant and/or advisory board member for AbbVie, Amgen, AnaptysBio, Arcutis, Avillon, Bristol-Myers Squibb, Celgene, Cipher, Eli Lilly, Galderma, Genentech, GlenMark, Incyte, Janssen, Kyowa, Leo Pharma, L’Oréal, Merck, Novartis, Pfizer, Sanofi and Valeant. Patrick Fleming has received honorarium and/or consulting and/or advisory boards and/or speaking fees for AbbVie, Altius, Amgen, Aralez, Bausch Health, Cipher, Eli Lilly, Galderma, Janssen, Leo Pharma, L’Oréal, Novartis, Pfizer, Sanofi-Genzyme and UCB.

Abstract:
Hair removal practices have evolved from adhering to social, cultural, and religious traditions to meeting aesthetic standards. Hair removal methods can be divided into two categories: 1) depilation, which involves removing the hair shaft and includes shaving and chemical depilatories, and 2) epilation, which involves removing the hair shaft, follicle, and bulb, and includes plucking, threading, waxing, sugaring, lasers, intense pulsed light system, electrolysis, and photodynamic therapy. Furthermore, an eflornithine hydrochloride 13.9% cream (Vaniqa®, neither an epilatory or depilatory technique), has been US FDA- and Health Canada-approved to slow the rate of facial hair growth and to be used in combination with other hair removal methods. Most methods are temporary except for electrolysis and laser therapy for some individuals, and each technique has advantages and disadvantages in terms of efficacy and adverse events. Importantly, most studies examining the efficacy of hair removal techniques are limited to darker hair and fairer skin, and further research is required especially for those with light-colored hair.

Key Words:
chemical depilatories, depilation, electrolysis, epilation, hair removal, laser hair removal, photodynamic therapy, plucking, shaving, sugaring, threading, Vaniqa, waxing

Introduction

Hair removal methods fall under two categories of depilation and epilation, each with distinctive advantages, disadvantages, and adverse events (Table 1).1 Depilation removes the hair shaft and includes techniques such as shaving and chemical depilatories. Epilation removes the hair shaft, follicle, and bulb, and includes techniques such as plucking, threading, waxing, sugaring, lasers, intense pulsed light system (IPL), electrolysis, and photodynamic therapy (PDT).1 In the 2000s, eflornithine hydrochloride cream 13.9% (Vaniqa®) was US FDA and Health Canada approved. Topical eflornithine is not considered an epilatory or depilatory technique but slows the rate of facial hair growth when used in conjunction with other methods.2

 

Hair Removal Method Advantages Disadvantages Adverse Events Permanency
Epilation
Shaving
  • Convenient
  • Inexpensive
  • Useful for larger area
  • Does not affect hair thickness or growth rate
  • Leaves blunt tips
  • Pseudofolliculitis
  • Skin abrasion
  • Skin irritation
Temporary
Chemical depilatories
  • Does not result in hair stiffness post-treatment
  • Easy to use and painless
  • Slower regrowth than shaving
  • Useful for larger areas
  • Less effective in removing darkly pigmented and coarse hair
  • Allergic contact dermatitis
  • Irritant contact dermatitis
Temporary
Depilation
Plucking
  • Inexpensive
  • Minimal skin damage
  • Slower regrowth period (2 to 12 weeks)
  • Does not affect hair growth rate unless hairs are in anagen phase
  • Efficacy dependent on user tolerance and technique
  • Impractical for larger areas
  • Tedious
  • Erythema
  • Follicular distortion
  • Folliculitis
  • Hyperpigmentation
  • Pain
  • Scarring
Temporary
Threading
  • Precise
  • Impractical for larger areas
  • Requires expertise
  • Tedious
  • N/A
Temporary
Waxing
  • Slower regrowth period than shaving or chemical depilatories
  • Useful for larger areas
  • May cause follicular trauma and reduce hair
    regrowth over time
  • Allergic reactions
  • Folliculitis
  • Scarring
  • Skin irritation
  • Thermal injury
  • Temporary
Temporary
Sugaring
  • Cost-effective
  • Hydrating
  • Reduces risk of skin redness, trauma, and scarring compared to shaving or hot wax
  • Safe and painless
  • Utilizes natural ingredients
  • Useful for larger areas
  • Can only remove hairs of sufficient length
  • Allergic reactions
  • Skin irritation
Temporary
Lasers
  • Can be permanent
  • Rapid hair removal
  • Useful for larger areas
  • Ineffective for thin vellus hairs, and white, grey, or red hairs
  • Increased adverse events in darker skin types
  • Blisters
  • Erythema
  • Eschar formation
  • First- & second-degree burns (diode laser)
  • Folliculitis (alexandrite laser)
  • Petechiae (Nd:YAG laser)
  • Pigmentation changes
  • Skin damage
  • Transient edema (Nd:YAG laser)
Temporary

Permanent
in some
individuals

Intense pulsed light system
  • Effective in darker hair and lighter skin types
  • Less expensive than laser therapy
  • Short treatment duration
  • Useful for larger areas
  • Less effective and may require more treatment sessions than laser therapy
  • Bulky/heavy device that is difficult to maneuver
  • Difficult to predict efficacy
  • Edema
  • Erythema
  • Hyperpigmentation
  • Hypopigmentation
  • Pain
Temporary
Electrolysis
  • Permanency
  • Efficacy dependent on operator’s skills
  • Impractical for larger areas
  • No standardization of licensure to practice
  • Patients with hirsutism will experience conversion of vellus to terminal hairs in treatment areas
  • Tedious; can be time-consuming
  • Crusting or follicular nodules with repeated insertions
  • Local infection or pain
  • Post-inflammatory hypo- or hyperpigmentation
  • Scarring/keloid formation
  • Transient erythema and edema
Permanent
Photo-dynamic therapy
  • Can be used in all skin and hair types
  • Reasonable alternative to lasers
  • Requires further investigations to be safely used for hair removal
  • N/A
Temporary
Other
Eflornithine hydrochloride 13.9% cream
  • Quick results (as early as 4 to 8 weeks)
  • Cannot be used alone
  • Only for facial application
  • Acne
  • Dizziness
  • Dry skin
  • Folliculitis
  • Indigestion
  • Itching or rash
  • Redness or irritation
  • Stinging or burning
  • Tingling
Temporary

Table 1: Hair removal methods – advantages, disadvantages, adverse events, and permanency

 


Hair Removal Methods

Depilation

Shaving

Shaving is a cost-efficient and popular technique for male facial hair and female underarm and leg hair removal.1,3 The two methods include: 1) wet shaving with a safety razor and 2) dry shaving with an electric razor.1,3 The first razors used in the 17th century had straight, fixed blades made of tempered steel which were dangerous to use and required regular maintenance (honing and stropping). In 1903, the revolutionary King Camp Gillette T-shape razor was introduced with the first double-edged disposable blade which did not require honing and stropping, but still needed direct handling for blade replacement. In the 1920s, the disposable injector blade was introduced, a safer and more convenient method without direct handling. In 1931, the razor blade was again revolutionized by the electric razor blade, which was costlier, but provided enhanced safety (the blade never directly touched the skin) and convenience (long-lasting and eliminated the need for shaving cream).3,4 Finally, in 1970, hoe-shaped safety razors with disposable cartridges were launched, and in 1975, the disposable razor was introduced. Both were safe to use, inexpensive, and convenient, with the disposable razor the most convenient of all models.5

Shaving (wet or dry) does not interrupt the anagen phase and, therefore, is a temporary hair removal method that necessitates frequent treatment.1,6 Shaving is convenient and inexpensive, but may cause irritation, skin abrasions, and pseudofolliculitis.1,7 Moreover, shaving does not change hair thickness or growth rate and leaves a blunt tip that appears to be thicker than uncut hair;3 thus, it is uncommon for facial hair removal in females.1

Chemical Depilatories

Chemical depilatories are made as powders, pastes, creams, or lotions,1,6,8 and used for the legs, bikini area, and face.3 Examples include detergents, hair-shaft-swelling agents, adhesives, pH adjusters, and bond-breaking agents, which disrupt disulfide bonds within keratin and provide temporary hair removal.3 The most common chemical depilatories are substituted mercaptans, 2% to 10% thioglycolates, mixed with 2% to 6% of sodium hydroxide or calcium hydroxide to increase pH.3,6,8 Sulfide depilatories and sodium hydroxide depilatories are unpopular as they cause greater irritant dermatitis and skin damage.3 Depilatories are applied to hairs for 3 to 15 minutes to dissolve the hair shaft, and are then washed off with soap and water.6,8

While chemical depilatories are easy to use, painless, have a slower regrowth than shaving, and do not result in stiffness of hairs post-treatment,3 they have unpleasant odors and may cause irritant contact dermatitis due to the alkalinity and allergic contact dermatitis due to fragrances.3,7 Thus, less than 1% of patients find facial application tolerable.7 Moreover, chemical depilatories are less effective in removing darkly pigmented and coarse hair.3

Epilation

Plucking

Plucking with tweezers temporarily removes hairs in small areas, and is most effective at removing terminal as opposed to vellus hairs, with the latter tending to break near the skin surface.1,3 Plucking is simple, inexpensive, causes minimal skin damage, and affords a longer regrowth period (2 to 12 weeks).3 However, plucking does not alter hair growth rate unless hairs are in the anagen phase, and can be a tedious process, making it impractical for use over larger areas.1 Plucking can cause discomfort or pain, and its efficacy is dependent on user tolerance and technique.1 Other drawbacks include folliculitis, follicular distortion, hyperpigmentation, erythema, and scarring.6-8

Threading

Threading involves the use of a twisted loop of cotton thread, with ends held by hand and teeth,3 that is pressed against the skin to trap and pull hairs.1,6 Threading is used in men to remove cheek, ear, and forehead hairs, and in women to remove facial hair.1,3, Threading is a temporary hair removal technique widely practiced in the Middle East and dates back to antiquity, also known as fatlah in Egypt, that has gained popularity in Western cultures due to its precision in shaping eyebrows.1 Threading, however, can be painful, tedious, and typically requires an esthetician with expertise.1

Waxing

Waxing is a popular, temporary hair removal method resulting in hair-free skin for 2 to 6 weeks depending on the individual’s hair growth rate and body site.1,3,7 Waxing is commonly used for larger areas.9 Wax is composed of beeswax and rosin with additives, essential oils, chemicals, and preservatives. Hot wax is preferred over cold wax especially in beauty salons9 as the heat dilates the follicular opening to facilitate hair removal.1,3,7 Once the wax cools and hardens, the strip is removed quickly in the direction opposite of hair growth.1,9

Waxing removes both vellus and terminal hairs in large areas, and is longer-lasting than shaving or chemical depilatories as hairs are removed from the bulb.1,3 Repeated waxing can cause follicular trauma and reduce hair regrowth over time.7,9 Other adverse events include folliculitis, thermal injury, skin irritation, scars,7,9 and allergic reactions to the additives.1,7 Patients using systemic retinoids are advised not to wax due to increased risk of scarring.

Sugaring

Sugaring is an ancient hair removal technique used in the Middle East and Egypt1 involving a paste composed of sugar, lemon juice, and water10 applied to skin in the direction of hair growth, then removed in the opposite direction with cloth.10 Sugaring has a similar application to waxing, but may remove shorter hairs (1/16 inch versus ¼ inch) as water-based pastes can more easily penetrate follicles.10 Moreover, sugaring is safe (utilizes natural ingredients), cost-effective, hydrating, painless, and can be used for larger areas,7 and reduces the risk of skin redness, trauma, and scarring compared to shaving or hot waxing.10 However, sugaring may cause skin irritation and allergic reactions1 and can only remove hairs of sufficient length.

Lasers

Laser hair removal can be permanent for some individuals,11 and involves selective photothermolysis that emits a light at a specific wavelength (nm), pulse duration, and fluence, causing thermal injury without damaging the skin.1,12 Light is either directly absorbed by melanin within the hair bulb and shaft6 or by an exogenous chromophore applied topically then absorbed by the follicle.1,6,12 Lasers are more effective when the pigmented hair shaft is intact; thus, plucking and waxing are discouraged, whereas depilation (e.g., shaving) is recommended pretreatment.1,12

Laser types include the ruby laser (694 nm),1,6,13 diode laser (800 nm),1,6,13-21 alexandrite laser (795 nm),1,18,22,23 and neodymium:yttrium-aluminum-garnet (Nd:YAG) laser (1064 nm),6,12,24,25 and efficacy depends on laser fluence, spot size, number of treatments and individual factors (e.g., skin type, hair type and hormonal status).26 Lasers work best for dark, thick terminal hairs, light/fair skin, and a normal hormonal status, but are ineffective for thin vellus hairs, and white, grey, or red hairs.26 Longer wavelengths reduce epidermal damage due to poor absorption and are therefore safe and effective in darker skin types. Cooling devices should also be used to reduce skin damage.16 Adverse events include immediate erythema,13edema, first- and second- degree burns,19,20 folliculitis,22,23 skin damage, pigmentation changes, blisters, and crust formation, and are more likely to occur in darker skin types [Fitzpatrick skin type (FST) III to VI].6,24

Intense Pulsed Light (IPL) System

The IPL system is a non-laser source of polychromatic light (550 nm to 1200 nm)6 tailored to individual skin type and hair color.1,6,24 Multiple treatments are typically required,1 however, results (60% hair reduction) may last up to 12 weeks after one session.27 For optimal results, individuals should avoid tanning but should shave prior to treatment to prevent conducting thermal energy to adjacent epidermis.1 IPL is most effective in individuals with the combination of darker hair and lighter skin.1

IPL has several advantages, including lower cost compared to laser hair removal and the ability to treat large surface areas (back, chest, and legs). However, IPL is generally less effective than laser hair removal, requires more treatment sessions,28 and the IPL device is bulky, heavy, and difficult to maneuver as it houses a lamp and cooling device.18 Adverse events include pain, edema, erythema, hypopigmentation, and hyperpigmentation.1,18,24 IPL devices can emit inconsistent fluence and wavelengths from pulse to pulse, making it difficult to predict efficacy.18

Electrolysis

Electrolysis is a permanent method of hair removal,1,6,8 but patients with hirsutism will experience conversion of vellus to terminal hairs in treatment areas. The three types of electrolysis [1) galvanic (direct current) electrolysis, 2) thermolysis (alternating current), and 3) combination/blend method] all involve inserting a probe to deliver electric currents that destroy and prevent regrowth of hair follicles.1

Galvanic electrolysis treatment is slow (15 seconds to 3 minute application per hair) with multiple treatments required; however, it can reduce the number of active hair follicles by 80% to 90%.1 This technique is tedious, time-consuming, painful, and can cause post-inflammatory hyperpigmentation and scarring, and is not recommended for larger areas requiring hair removal.8 In contrast, thermolysis is faster than galvanic electrolysis due to a shorter skin contact time, but generally less effective – hair has been found to regrow in 20% to 40% of follicles post-treatment.1 The blend method (combination of galvanic electrolysis and thermolysis) is considered the most effective form, as it is as fast as thermolysis and less painful than galvanic electrolysis.1

Adverse events of electrolysis depend on current type, duration, and intensity, but include pain, scarring/keloid formation in susceptible patients, and post-inflammatory hypo- or hyperpigmentation. Topical anesthetics can be offered before treatment, however maintaining sensation is preferred as pain is related to skin damage.6 Erythema and edema are common but transient, and crusting or follicular nodules may form with repeated insertion of a needle into the same follicle. There is also risk of local infection if instruments are not cleaned properly; operators should wear gloves at all times and apply antibacterial ointment to the area post-treatment.6 The efficacy of electrolysis depends largely on the operator’s skills, and unfortunately there is no standardization of licensure to practice this technique.1,6

Photodynamic Therapy (PDT)

PDT involves the application of a topical photosensitizer6 and subsequent exposure to nonionizing radiation of red light (635 nm) through a projector, broadband light device, or laser.29 Light is absorbed by a photosensitizer, subsequently forming singlet oxygen that causes lipid peroxidation of follicular cell membranes and protein damage,6,8 resulting in phototoxic effects on hairs.30 The most common topical agents used for PDT are 10% or 20% topical 5-aminolevulinic acid (5-ALA) and methyl aminolevulinate – prodrugs that lead to the formation of a photosensitizer, protoporphyrin IX (PPIX). PDT treatment duration is dependent on the incubation time of 5-ALA, which should be sufficient to allow for its conversion to PPIX. The incubation period for 5-ALA is typically 3 hours29 followed by brief light exposure.31 PDT can be used in all skin and hair types as its mechanism of action is independent of melanin concentration and has minimal side-effects.30 Uebelhoer et al. described a 40% hair reduction at 6 months of wax epilated areas after ALA application for 3 hours with one treatment of irradiation with continuous wave 630 nm red light.32 Moreover, in a recent study by Comacchi et al. on the use of PDT in idiopathic hirsutism and hypertrichosis, two to five treatments (with a 1 month period between treatments) led to a 75% hair reduction at 12 months.30 Since PDT is primarily used to treat cutaneous malignancy, its use in hair removal is limited and further investigations are required.8,12

Other

Topical Eflornithine Hydrochloride

Eflornithine hydrochloride 13.9% cream (Vaniqa®), is a topical prescription medication that is not meant to be used alone and should be combined with another hair removal technique. Topical eflornithine does not fall under epilation or depilation as it does not remove hair but rather slows facial hair growth, and inhibition of ornithine decarboxylase is the postulated mechanism of action. If applied twice daily at least 8 hours apart, results may be seen as early as 4 to 8 weeks. Adverse event rates include acne, folliculitis, stinging or burning, dry skin, itching, tingling, redness or irritation, indigestion, rash, and dizziness. Patients should consult their physician before using eflornithine if pregnant, planning pregnancy, or breastfeeding.2

Conclusion

This article is a general overview of hair removal practices, which have evolved from utilizing waxes and blades, to advanced lasers and electrolysis, with further advancements still being studied.1 Residual, unwanted hair is a common problem for many individuals and traditional methods of hair removal (e.g., shaving and waxing) have provided temporary solutions and unsatisfactory results. Laser therapy is a safe modality that can produce permanent results in some individuals.11,12 Electrolysis is a permanent hair removal method but can be tedious and associated with several adverse events. A relatively recent FDA and Health Canada approved treatment, eflornithine hydrochloride 13.9% cream, can be used in combination with another hair removal technique to slow the rate of facial hair growth. Importantly, studies examining hair removal efficacy are limited to individuals with darker hair and fairer skin, whereby precautionary measures such as cooling devices are recommended for safe treatment. Further research is required to develop safe and effective treatments for those with lighter-colored hair.12

References



  1. Fernandez AA, Franca K, Chacon AH, et al. From flint razors to lasers: a timeline of hair removal methods. J Cosmet Dermatol. 2013 Jun;12(2):153-62.

  2. Vaniqa® (eflornithine hydrochloride) cream, 13.9% [Prescribing information]. Revised January 2018. Allergan USA, Inc., Madison, NJ. Available at: https://media.allergan.com/actavis/actavis/media/allergan-pdf documents/productprescribing/20180128-VANIQA-USPI-73326US11.pdf. Accessed August 10, 2021.

  3. Ramos-e-Silva M, de Castro MC, Carneiro LV, Jr. Hair removal. Clin Dermatol. 2001 Jul-Aug;19(4):437-44.

  4. Rietzler M, Maurer M, Siebenhaar F, et al. Innovative approaches to avoid electric shaving-induced skin irritation. Int J Cosmet Sci. 2016 Jun;38 Suppl 1:10-6.

  5. Retallack GB. Razors, shaving and gender construction: an inquiry into the material culture of shaving. MCR [Internet]. 1999 Jan 01;49(1). Available from: https://journals.lib.unb.ca/index.php/MCR/article/view/17782. Accessed August 12, 2021.

  6. Olsen EA. Methods of hair removal. J Am Acad Dermatol. 1999 Feb;40(2 Pt 1):143-55; quiz 56-7.

  7. Wanitphakdeedecha R, Alster TS. Physical means of treating unwanted hair. Dermatol Ther. 2008 Sep-Oct;21(5):392-401.

  8. Ort RJ, Anderson RR. Optical hair removal. Semin Cutan Med Surg. 1999 Jun;18(2):149-58.

  9. Khanna N, Chandramohan K, Khaitan BK, Singh MK. Post waxing folliculitis: a clinicopathological evaluation. Int J Dermatol. 2014 Jul;53(7):849-54.

  10. Lim V, Simmons BJ, Maranda EL, et al. Sugaring-Modern Revival of an Ancient Egyptian Technique for Hair Removal. JAMA Dermatol. 2016 Jun 1;152(6):660.

  11. Altunel CT, Kartal SP. Reconceptualizing the permanence of alexandrite laser hair removal results: a long-term follow-up study. J Cosmet Laser Ther. 2020 Nov 16;22(6-8):271-4.

  12. Dierickx CC. Hair removal by lasers and intense pulsed light sources. Dermatol Clin. 2002 Jan;20(1):135-46.

  13. Elman M, Klein A, Slatkine M. Dark skin tissue reaction in laser assisted hair removal with a long-pulse ruby laser. J Cutan Laser Ther. 2000 Mar;2(1):17-20.

  14. Adrian RM, Shay KP. 800 nanometer diode laser hair removal in African American patients: a clinical and histologic study. J Cutan Laser Ther. 2000 Dec;2(4):183-90.

  15. Barolet D. Low fluence-high repetition rate diode laser hair removal 12-month evaluation: reducing pain and risks while keeping clinical efficacy. Lasers Surg Med. 2012 Apr;44(4):277-81.

  16. Campos VB, Dierickx CC, Farinelli WA, et al. Hair removal with an 800-nm pulsed diode laser. J Am Acad Dermatol. 2000 Sep;43(3):442-7.

  17. Campos VB, Dierickx CC, Farinelli WA, et al. Ruby laser hair removal: evaluation of long-term efficacy and side effects. Lasers Surg Med. 2000 26(2):177-85.

  18. Gan SD, Graber EM. Laser hair removal: a review. Dermatol Surg. 2013 Jun;39(6):823-38.

  19. Greppi I. Diode laser hair removal of the black patient. Lasers Surg Med. 2001 28(2):150-5.

  20. Royo J, Urdiales F, Moreno J, et al. Six-month follow-up multicenter prospective study of 368 patients, phototypes III to V, on epilation efficacy using an 810-nm diode laser at low fluence. Lasers Med Sci. 2011 Mar;26(2):247-55.

  21. Wheeland RG. Simulated consumer use of a battery-powered, hand-held, portable diode laser (810 nm) for hair removal: A safety, efficacy and ease-of-use study. Lasers Surg Med. 2007 Jul;39(6):476-93.

  22. Garcia C, Alamoudi H, Nakib M, et al. Alexandrite laser hair removal is safe for Fitzpatrick skin types IV-VI. Dermatol Surg. 2000 Feb;26(2):130-4.

  23. Kutlubay Z. Alexandrite laser hair removal results in 2359 patients: a Turkish experience. J Cosmet Laser Ther. 2009 Jun;11(2):85-93.

  24. Fayne RA, Perper M, Eber AE, et al. Laser and Light Treatments for Hair Reduction in Fitzpatrick Skin Types IV-VI: A Comprehensive Review of the Literature. Am J Clin Dermatol. 2018 Apr;19(2):237-52.

  25. Goldberg DJ, Littler CM, Wheeland RG. Topical suspension-assisted Q-switched Nd:YAG laser hair removal. Dermatol Surg. 1997 Sep;23(9):741-5.

  26. Haedersdal M, Beerwerth F, Nash JF. Laser and intense pulsed light hair removal technologies: from professional to home use. Br J Dermatol. 2011 Dec;165 Suppl 3:31-6.

  27. Gold MH, Bell MW, Foster TD, et al. Long-term epilation using the EpiLight broad band, intense pulsed light hair removal system. Dermatol Surg. 1997 Oct;23(10):909-13.

  28. Thaysen-Petersen D, Bjerring P, Dierickx C, et al. A systematic review of lightbased home-use devices for hair removal and considerations on human safety. J Eur Acad Dermatol Venereol. 2012 May;26(5):545-53.

  29. Touma DJ, Gilchrest BA. Topical photodynamic therapy: a new tool in cosmetic dermatology. Semin Cutan Med Surg. 2003 Jun;22(2):124-30.

  30. Comacchi C, Bencini PL, Galimberti MG, et al. Topical photodynamic therapy for idiopathic hirsutism and hypertrichosis. Plast Reconstr Surg. 2012 Jun;129(6):1012e-4e.

  31. Shin H, Yoon JS, Koh W, et al. Nonpigmented hair removal using photodynamic therapy in animal model. Lasers Surg Med. 2016 Oct;48(8):748-62.

  32. Uebelhoer NS, Dover JS. Photodynamic therapy for cosmetic applications. Dermatol Ther. 2005 May-Jun;18(3):242-52.


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Update on Drugs & Devices: September – October 2021 https://www.skintherapyletter.com/drug-updates/sep-oct-2021/ Fri, 10 Sep 2021 16:55:56 +0000 https://www.skintherapyletter.com/?p=12776 Tazarotene lotion, 0.045%

Trade Name: Arazlo™
Company: Bausch Health

Approval Dates/Comments: In August 2021, Health Canada approved tazarotene lotion, 0.045%, for the topical treatment of acne vulgaris in patients ≥10 years of age. This is the first preparation of tazarotene available in a lotion form. It is formulated using Prismatrex™ technology (a novel polymeric emulsification system that may alleviate skin dryness), which has been shown to provide strong efficacy with good tolerability.


Anifrolumab-fnia IV use

Trade Name: Saphnelo™
Company: AstraZeneca

Approval Dates/Comments: The US FDA approved anifrolumab in July 2021 for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy. The approval was based on efficacy and safety data from the Saphnelo™ clinical development program, including two TULIP Phase III trials and the MUSE Phase II trial. In these trials, more patients treated with anifrolumab experienced a reduction in overall disease activity across organ systems, including skin and joints, and achieved sustained reduction in oral corticosteroid use compared to placebo, with both groups receiving standard therapy. This marks the first regulatory approval for a type I interferon receptor antagonist and the only new treatment approved for SLE in more than 10 years.


Immune globulin intravenous (human) 10%

Trade Name: Octagam® 10%
Company: Octapharma

Approval Dates/Comments: In July 2021, the FDA granted approval to Octagam® 10% (immune globulin intravenous [human]), the first and only intravenous immunoglobulin (IVIg) to be indicated for the treatment of adult dermatomyositis. Regulatory approval was based on the positive results of the ProDERM study.


Odevixibat capsule

Trade Name: Bylvay™
Company: Albireo Pharma

Approval Dates/Comments: In July 2021, the FDA approved this non-systemic ileal bile acid transport inhibitor for the treatment of pruritus in all subtypes of progressive familial intrahepatic cholestasis. Treatment is administered as a once-daily capsule or opened and sprinkled onto soft foods.


Pembrolizumab IV use

Trade Name: Keytruda®
Company: Merck

Approval Dates/Comments: In July 2021, the FDA expanded the approval for this programmed cell death protein 1 (PD-1) inhibitor to include locally advanced cutaneous squamous cell carcinoma not curable by radiation or surgery.


Tretinoin/benzoyl peroxide cream, 0.1%/3%

Trade Name: Twyneo®
Company: Sol-Gel Technologies
Galderma

Approval Dates/Comments: In July 2021, the FDA approved a fixed-dose combination of a retinoid (tretinoin 0.1%) with an antibacterial agent (benzoyl peroxide [BP] 3%) for the once-daily, topical treatment of acne vulgaris in patients ≥9 years of age. This fixed-drug medication is formulated with a patented technology to entrap tretinoin and BP within silica-based microcapsules to stabilize tretinoin from being degraded by BP and to slowly release both active drugs over time to provide a favorable efficacy and safety profile.


Chlormethine hydrochloride gel

Trade Name: Ledaga™
Company: Recordati Rare Diseases

Approval Dates/Comments: Health Canada approved this antineoplastic agent in June 2021 for the topical treatment of stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in adult patients who have received prior skin-directed therapy.


HA injectable filler

Trade Name: Restylane® Contour
Company: Galderma

Approval Dates/Comments: The FDA approved this hyaluronic acid (HA)-based dermal filler in June 2021 for cheek augmentation and correction of midface contour deficiencies in adults aged >21 years.

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