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Disparities in geographic diversity, enrollment, and reporting trends for hyperhidrosis clinical trials

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Presented at: Society for Investigative Dermatology 2025

Date: 2025-05-07 00:00:00

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Summary: Abstract Body: The prevalence of hyperhidrosis varies globally, with higher rates documented in Asian populations. Despite its burden and growing therapeutic landscape, limited data exists on the diversity of populations in clinical trials. While the underrepresentation of racial and ethnic minorities in dermatology trials is well-documented, trends in hyperhidrosis trials remain unexplored. This study evaluates the geographic diversity, enrollment, and reporting of racial and ethnic minorities in phase II and III randomized control trials (RCTs) for hyperhidrosis. Completed clinical trials for hyperhidrosis conducted between January 2000 and November 2024 were identified through ClinicalTrials.gov and PubMed. Race and ethnicity demographics were extracted for each RCT. A total of 32 trials with 4,904 participants met inclusion criteria. Majority of the trials (n=22, 68.8%) were conducted in the last decade, with the United States being the most common location (n=22, 62.5%), followed by Germany (n=4, 12.5%), Canada (n=3, 9.4%), and France (n=2, 6.3%). Only 16 (50%) of trials reported race and/or ethnicity data. Of the 4,904 participants, 2,678 (54.6%) were White, 500 (10.2%) were Black/African American, 199 (4%) were Asian, 70 (1.4%) were more than one race, 15 (0.3%) were American Indian/Alaska Native, and 13 (0.3%) were Native Hawaiian/Pacific Islander. The remaining 1,429 participants (29.1%) were unknown or not reported. Furthermore, Hispanic or Latino ethnicity was reported in only 636 (13%) participants. These findings reveal significant gaps in reporting and participant diversity in hyperhidrosis RCTs, with nearly a third of participants lacking demographic. Trials are heavily concentrated in North America and Europe, with minimal representation from other regions. Future trials must expand to underrepresented global regions, improve participant diversity, and mandate standardized reporting of race and ethnicity data to ensure equitable outcomes and better reflect the global burden of hyperhidrosis. Aditya Joshi<sup>1</sup>, Lauren Gawey<sup>1</sup>, Khiem Tran<sup>1</sup>, Jennifer Hsiao<sup>2</sup>, Vivian Y. Shi<sup>1</sup> 1. Dermatology, University of Washington, Seattle, WA, United States. 2. Dermatology, University of Southern California, Los Angeles, CA, United States. Minoritized Populations and Health Disparities Research