An Update to Ethnoracial Gaps in Global Hidradenitis Suppurativa Clinical Trials.

Abstract

Introduction: Hidradenitis suppurativa (HS) disproportionately affects ethnoracial minority populations, particularly Black and Hispanic individuals. However, representation in randomized controlled trials remains limited. We aim to assess ethnoracial representation and reporting in HS trials conducted over the past 5 years.

Methods: Phase 2 and 3 trials completed between 2019 and 2025 were identified via ClinicalTrials.gov. Trials with results and publications were included. Participant ethnoracial data were extracted, and PubMed supplemented missing data.

Results: Among the 17 trials included in analysis, 76.2% (n = 2,652) of participants were white, 13.0% (n = 451) Black/African American, 6.0% (n = 210) Asian, 1.9% (n = 66) more than one race, 1.0% (n = 36) American Indian or Alaska Native, and 0.1% (n = 4) Native Hawaiian or other Pacific Islander. A total of 5.2% (n = 181) were Hispanic/Latino, although only 58.8% (n = 10) of trials reported these data. Of remaining participants, 1.8% (n = 63) were recorded as "unknown/not reported." Geographically, all 17 (100%) trials had site locations in North America, 70.6% (n = 12) of trials had a site location in Europe, 41.2% (n = 7) in Australia, 41.2% (n = 7) in Asia, 11.8% (n = 2) in South America, and 5.9% (n = 1) in Africa.

Conclusions: We found improved reporting of race and ethnicity in global HS clinical trials, yet Black and Hispanic/Latino patients remain underrepresented. Additionally, a lack of trials conducted in Africa, Asia, and South America could explain the lack of a global representation in participant demographics. Future trials should conduct stratified analyses to evaluate efficacy across global populations.