Race and Ethnicity Reporting in U.S. Acne Clinical Trials: Hispanic/Latino Representation in Phase II-IV Studies, 2017-2025

A study set for online publication September 3, 2026 in the Journal of the American Academy of Dermatology, by Jennifer Keelin, Daniela Baboun, and Jonette E. Keri, examines how consistently U.S. acne trials in Phase II through IV reported race and ethnicity data between 2017 and 2025. The timeframe matters: it spans the period before and after federal diversity-reporting mandates took effect, letting the authors ask whether policy changes actually moved the needle on who gets counted in acne research.

That question builds on a body of prior work showing spotty reporting practices across dermatology broadly. A 2023 analysis published via PubMed and ScienceDirect found that of 246 dermatology trials, 87.4% reported racial data, but only 61.8% reported ethnicity, meaning Hispanic or non-Hispanic origin was frequently left out even when race was tallied. An earlier review focused specifically on acne, atopic dermatitis, and psoriasis trials found race and ethnicity reported in just 22.7% of studies, with Hispanic participation reaching only 16.3% in non-topical trials and 18.7% in Phase III trials, both below the Hispanic share of the U.S. population.

The clinical stakes of that gap are not abstract. A post hoc analysis of two Phase 3 sarecycline trials, published in PMC, noted that acne affects an estimated 32% of Hispanic women compared to 24% of Caucasian women, and found a statistically significant reduction in acne among the 550 Hispanic patients in its intent-to-treat population, most starting with moderate disease. When ethnicity is not reported, or Hispanic participants are enrolled in low numbers, findings like that one become harder to replicate or generalize at the population level the disease actually affects.

Federal policy has been in flux throughout the window this new study covers. The FDORA of 2022 required sponsors to submit Diversity Action Plans for certain trials, according to a summary from Imperial Clinical Research Services, but the FDA's guidance document was briefly pulled from its website on January 24, 2025, following an executive order, before a court ordered it restored on February 11, 2025, now accompanied by a memo from the administration, per reporting from Columbia Law School's climate law blog and a follow-up post from Leapcure. A parallel cohort study of U.S. clinical trials found industry funding was negatively associated with race and ethnicity reporting altogether, with an adjusted odds ratio of 0.42, suggesting the incentives shaping who gets counted extend well beyond acne research alone.

What the Keelin, Baboun, and Keri paper adds, based on its scope, is a acne-specific accounting through 2025, the year the mandate's guidance wavered and was restored. Whether that regulatory whiplash shows up as a measurable shift in enrollment data, rather than just reporting language, is precisely the kind of before-and-after comparison the 2017-2025 window was built to test.