Why Are Clinical Trials for Skin-Care Products Primarily Done on Light-Skinned People?

The clinical trials conducted to test the efficacy of skin-care products can be vital to that product’s success. Though they cost a pretty penny and not every brand can afford to do them, especially in their early days, we at NewBeauty hold them in high regard because they give us the necessary proof to back up big claims. For example, if a brand says its serum can smooth wrinkles in two weeks, show us proof.

However, one major gripe many dermatologists and skin-care experts (and beauty editors) have with these clinical trials is that they’re notorious for leaving out participants with darker skin tones. Here, we talk to top dermatologists to find out why this is the case, and how it can be improved so more skin tones are fairly represented.

2 Reasons Why It Happens Lack of product regulation

“Clinical studies for skin-care products are not regulated like they are for pharmaceutical agents or drugs,” says Glenn Dale, MD dermatologist Valerie Callender, MD. “The latter are regulated by the FDA and there is a requirement for studies to include a percentage of African Americans that matches the U.S. population. Therefore, the beauty industry would have to make a conscious decision and effort to include all skin types in their studies, which would expand the market.”

Montclair, NJ dermatologist Jeanine Downie, MD adds that because many of these products are considered cosmeceuticals, the situation is tricky and the FDA does not specifically regulate them. “There needs to be an industry-wide standard where all skin types are included in clinical trials to make it more inclusive for everyone,” she says. “Actual laws being passed is difficult, because like I said, the FDA does not oversee cosmeceuticals unless they are making wild and ridiculous claims. Additionally, unfortunately many investigators and companies think it is not necessary to test various skin-care products on all skin types, but it is.” 

Recruitment bias and ease

“Clinical trials have historically been done on lighter skin types because most of the investigators were also lighter skin types and either didn’t have the patient population to support darker skin types participating or didn’t think to include these patients,” says Birmingham, AL dermatologist Corey Hartman, MD. “Also, there is a history of racism and abuse in clinical trials in America that gives many melanated people pause when they consider participating in them. For example, the Tuskegee Study experiments, Henrietta Lacks, etc.” To this point, Dr. Downie adds, “sometimes lighter-skinned patients are easier to recruit.”

Is Change Finally Happening?

“Previously and erroneously, there was not a major emphasis put on ensuring representation of a broad range of skin types were included in these clinical trials,” says Hamden, CT dermatologist Mona Gohara, MD, noting that clinical trials were amongst many other elements of dermatology that required attention to increase in diversity, equity and inclusion (DEI). “With a more recent reckoning that all aspects of our specialty [dermatology] and science should take into account every patient, not just a select few, the tide has appropriately turned. The only thing that needs to happen is a commitment to change—nothing complicated at all.”

According to Dr. Hartman, positive change is in motion. “This has been a super hot topic since 2020, bringing more awareness to the issue. Plus, the FDA has come down on some brands and not given final approval for many drugs because the trials weren’t inclusive enough.” This gives hope that the same due diligence will be given to skin-care brands as they pursue and conduct their own trials.

We also have to give credit to the brands who do ensure a diverse group of skin tones in their studies, setting a great example for their peers. “Fortunately, there are many companies like AbbVie/Allergan, L’Oréal, SkinMedica and Obagi that always test on all skin types,” Dr. Downie adds.

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