A Step Toward Inclusive Dermatologic Trials: Addressing Gaps in Skin of Color Research

In 1993, the NIH passed the Revitalization Act, a landmark step toward equitable clinical research efforts.¹ This legislation mandated the inclusion of women and minorities in all NIH-funded studies, ultimately requiring trials to be designed in a manner that adequately reports on and represents these groups. This was a long-overdue recognition that effectiveness, a measure of how well treatments work in real-world settings, cannot be accurately approximated without representative sampling.

Prior to this mandate, many clinical trials, even those investigating common conditions, excluded women and people of color, either by design or by default. As a result, despite their recommended use, many interventions had poor true generalizability supported by research data, leaving clinicians with limited data to guide care for diverse populations. This key legislation; however, has limited jurisdiction, only applying to NIH-funded research, which remains a small fraction of research output. In dermatology, for instance, just 3.6%-4.4% of clinical trials are currently NIH-funded, while up to 60% are funded by industry sources.² This mirrors a majority of today’s medical research overall, of which industry sponsors fund up to 70%. ³ This striking imbalance has consequences, as industry-led studies often lack standardization in demographic reporting by gender, race, ethnicity, or, in the case of dermatologic clinical trials, skin type.

The lack of inclusive trial design and reporting is particularly alarming in dermatology, where skin tone can significantly influence disease presentation and treatment outcomes. Yet many studies still fail to report participant race, and even fewer include Fitzpatrick Skin Type (FST), a useful measure when evaluating how treatments work across different complexions. In the case of acne, one of the most common dermatologic conditions, darker-skinned patients often experience postinflammatory hyperpigmentation (PIH), which can linger long after acne lesions have cleared, with significant psychosocial implications. Yet despite its prevalence and impact, PIH is rarely included as a primary or even secondary endpoint in acne trials. A recent review found that of all acne trials reported on clinicaltrials.gov, only 3% focused explicitly on skin of color, and just 2.4% measured PIH as an outcome.⁴ Only two studies included PIH as a primary endpoint.

Atopic dermatitis (AD) is another condition where collecting demographic data, particularly of race and skin type, can have profound implications on assessing efficacy. In the United States, AD disproportionately affects Black children, both in both severity and prevalence, also leaving behind pigmentary changes like PIH. Yet pigmentary outcomes are rarely considered in AD trials. Physicians are left to rely on case reports, such as a 2020 study showing that dupilumab improved both AD symptoms and PIH in a patient with darker skin.⁵ To fully understand the broader impact of future interventions, subsequent studies must address systemic underrepresentation.

This holds true for other chronic skin conditions as well, many of which may be more systemic in nature, like hidradenitis suppurativa (HS) and systemic lupus erythematosus (SLE), which also disproportionately affect marginalized groups. Representative trials for these conditions and many others require concerted efforts toward ensuring that recruitment and retention of participants reflect the racial, gender, and socioeconomic diversity of the patients who endure these conditions.

Despite these longstanding gaps, there are several efforts toward progressive change. Some recent studies show improvement in inclusion metrics. Leading journals and organizations have called for routine reporting of race, ethnicity, gender, and Fitzpatrick type, and recommend intentional recruitment strategies that engage historically underrepresented groups.

A standardized framework for inclusive design and reporting is critical. However, researchers and sponsors must go beyond compliance and ask hard questions:

• How might our recruitment practices systemically exclude certain populations?
• Are we measuring what matters to the people most affected by this condition?

Even the most rigorous randomization does not protect against bias if samples are not representative. Community partnerships, transportation support, decentralized trial sites, and multilingual materials can all reduce barriers to participation. However, none of this works without trust, transparency, consistency, and cultural humility. A study on psoriasis trials found that cross-cultural training for research staff and inclusive engagement strategies significantly improved diverse recruitment.⁶

Standardized frameworks for inclusive trial design and reporting are increasingly needed as the demographics of the United States shift. That means requiring demographic and FST data in all dermatology trials, ensuring outcomes are relevant across all populations, and prioritizing subgroup analyses that reflect real-world variation. Equity through this approach is fundamental to good science. For future dermatologic interventions to truly serve all patients, research must be designed with all patients in mind.