Hyperhidrosis Clinical Trial Disparities: Enrollment and Reporting Trends

Area of Science:

• Clinical Trials
• Dermatology
• Public Health

Background:

• Hyperhidrosis, a condition causing excessive sweating, significantly impacts quality of life.
• While new treatments exist, clinical trial data may not apply broadly due to underrepresentation of diverse populations.

Purpose of the Study:

• To analyze geographic distribution, racial/ethnic representation, and demographic reporting in hyperhidrosis randomized controlled trials (RCTs).
• To identify trends in diversity and reporting within hyperhidrosis research.

Main Methods:

• A systematic search of ClinicalTrials.gov identified completed phase 2 and 3 interventional RCTs for hyperhidrosis (2005-2024).
• Demographic data, including race and ethnicity, were extracted from trial registries and publications.
• Geographic representation was analyzed by continent.

Main Results:

• Thirty-two RCTs involving 4,904 participants were included; 62.5% were US-based.
• Only 53.1% of trials reported race/ethnicity, with White participants being the majority (55.1%).
• Reporting of race/ethnicity improved over time, but geographic diversity decreased.

Conclusions:

• Nearly half of hyperhidrosis RCTs do not report essential demographic data.
• Limited racial/ethnic and geographic diversity in trials hinders the generalizability of findings.
• There is a critical need for more inclusive study designs in hyperhidrosis research.