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First page of Hyperhidrosis Clinical Trial Disparities: Enrollment and Reporting Trends

Introduction Hyperhidrosis is a chronic condition of excessive sweating with a significant impact on quality of life. Although recent therapeutic advances have expanded treatment options, clinical trial data may lack generalizability due to underrepresentation of diverse populations. This study examined geographic distribution, racial/ethnic representation, and demographic reporting trends in randomized controlled trials (RCTs) for hyperhidrosis. Methods A search of ClinicalTrials.gov in November 2024 identified completed phase 2 and 3 interventional RCTs for hyperhidrosis from 2005-2024. Demographics were extracted from trial registries and associated PubMed publications. Race and ethnicity were categorized per U.S. Census definitions, and geographic representation was analyzed by continent. Results Thirty-two RCTs with 4904 participants were included. Most were U.S.-based (62.5%) and only 53.1% reported race/ethnicity. Among reported participants, 55.1% were White, 10.3% Black, 4.1% Asian, and 13% Hispanic/Latino. Race/ethnicity were unknown or unreported for 28.5% of participants. Reporting improved over time (race: 30% to 63.6%; ethnicity: 20% to 50%), while geographic diversity declined. Conclusion Nearly half of hyperhidrosis RCTs failed to report race/ethnicity, and participant diversity remains limited despite improvements. Limited racial/ethnic and geographic diversity undermines the generalizability of trial findings and highlights the need for more inclusive study designs.

S. Karger AG, Basel
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2025
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