Cosmetic clinical trials must be planned with diversity as a priority

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Medical research has a long, unfortunate track record of excluding ethnic and racial minority groups from clinical trials, a phenomenon that introduces remarkable uncertainty to the outcomes of taking medications or receiving laser-based medical treatments in these populations. Similarly, chronic medical conditions and adverse reactions to treatment that disproportionately affect minority groups, such as people of color, have historically garnered less investigative attention than those that affect majority groups. This has led to increased morbidity and mortality in minority groups.

The U.S. Census Bureau projects that people with skin of color will constitute 50.3% of the U.S. population by 2045, up from 39.7% in 2019. As this minority population grows, so could the disparities. Since change is unlikely without intervention, a team of researchers — in conjunction with the American Society for Laser Medicine and Surgery Inc. (ASLMS) — recently set out to characterize some of these disparities in the field of cosmetic dermatology.

Cosmetic dermatology employs a variety of techniques — including injectable neuromodulators, soft-tissue fillers, and laser treatments — to smooth wrinkles, correct skin blemishes, and treat a variety of dermatologic conditions. But even for these well-studied techniques, safety protocols vary significantly. In laser treatment, for example, the lasers used for hair removal or cosmetic surgery have a defined safety profile for people with lighter skin tones. But people with darker skin tones who receive such laser treatment face an increased risk of side effects — scarring, blistering, or post-inflammatory dyspigmentation, for example — making therapy for such patients more technically complex. The tendency for people of color to suffer more side effects from laser treatment, combined with the limited research available on laser therapy efficacy on darker skin tones, requires using the utmost caution when treating this growing market.

Incentivizing industry to increase diversity in clinical trials is in society’s best interest.
Additional challenges are specific to aesthetic dermatology. For example, anatomical variations across different populations affect cosmetic outcomes. If clinicians study procedures such as filler placement only on white patients, the clinicians’ knowledge may not be applicable to patients of East Asian descent, who often have different distributions of facial fat than white patients have, for instance. Additionally, filler placement among patients of color is typically focused on the center of the face and on the under-eye area, while data shows that white patients prefer placement in the lips as well. These preferences also speak to social or ethnic conceptions of beauty, which can vary markedly across demographics.

My colleagues and I conducted a study of 318 cosmetic and aesthetic surgeries that were performed over the last 30 years. We found that industry-sponsored trials (as opposed to investigator-initiated ones) were significantly less likely to include people of color than non-industry-sponsored trials. Over half of all trials neglected to report any racial or ethnic breakdowns of their study populations at all. Increasing the recruitment of people of color into trials is complex due to issues that include socioeconomic status, geography, and historical mistreatment of minority groups in research settings. But incentivizing industry to increase diversity in clinical trials is in society’s best interest.

From a governance perspective, supporting the passage of legislation such as the DIVERSE Trials Act could introduce diversity into clinical trials by requiring the FDA to issue guidance related to encouraging participation from a broader and more decentralized population. Such legislation would also encourage reporting of racial and ethnic demographic data. Funding studies of techniques or types of equipment that are more commonly used on or preferred by people of color — Nd:YAG lasers, for example, which have longer wavelengths and are safer for darker skin — will help clinicians to better understand patient preferences and possible procedural outcomes, opening the door to more efficacious and aesthetic outcomes. Finally, increasing outreach to people of color through community-based approaches to request their participation in clinical trials could improve their representation in those trials.


The author would like to acknowledge his co-authors in the study of minority representation in cosmetic clinical trials. Titled “Skin of color representation in cosmetic clinical trials: A literature review,” the study was spearheaded by members of ASLMS, including the leader of the group, Lisa Akintilo, M.D., of the Ronald O. Perelman Department of Dermatology at NYU Grossman School of Medicine. Other members include Oge Onwudiwe, M.D., from AllPhases Dermatology in Alexandria, Va.; Kachiu Lee, M.D., from Main Line Center for Laser Surgery in Ardmore, Pa.; and Lilit Garibyan, M.D., from the Department of Dermatology at Harvard Medical School.

Meet the author

Akshay Pulavarty received a master’s degree in public health from the University of Virginia. He is an M.D. candidate at NYU Grossman School of Medicine. Pulavarty is an author of “Skin of color representation in cosmetic clinical trials: A literature review,” a study that was published in Lasers in Surgery and Medicine, the official journal of the American Society for Laser Medicine and Surgery in 2021.

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Published: October 2022
BioOpinionminoritieslaser treatmentASLMSdermatologydyspigmentationDiverse Trials ActFDA

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