Racial and Ethnic Disparities in Androgenetic Alopecia Clinical Trials in the United States

Introduction: Androgenetic alopecia (AGA) is the most common type of hair loss worldwide and is estimated to affect about 80 million people in the United States. Recent trends suggest that incidence and severity of the disease are increasing across all genders and races. Randomized controlled trials (RCTs) involving diverse patient populations are necessary to individualize treatment. Objective: Evaluate enrollment and subgroup analysis of people falling in racial/ethnic minority groups in phase II and III RCTs for AGA published in the United States within the past 10 years. Methods: We examined completed published phase II and III randomized, double-blind, placebo-controlled trials investigating AGA. Race/ethnicity data was extracted for each RCT using US Census Bureau guidelines. Results: 20 total RCTs with a total of 1855 participants were included in the analysis. 8 (40%) of RCTs included race/ethnicity data. Among these, 3 (15%) studies included only race and 5 (25%) included both. The majority of study patients were white (n= 862/1063, 81.1%) followed by African American (n=127/1063, 11.9%) and Asian (n=33/1063, 3.1%). Six (0.56%) patients identified as American Indian/Alaska Natives, 5 (0.47%) as Hawaiian/Pacific Islander, and 16 (1.5%) as another race or race was unknown. Ethnicity was reported in 5 (25%) of trials, totaling 317 participants; 60 (18.9%) patients identified as Hispanic. Conclusions: Non-Caucasian patients remain underrepresented in RCTs despite AGA being a highly prevalent condition, reducing the generalizability of trial outcomes to the general population. Future RCTs should update definitions of race/ethnicity and include more diversity among AGA patients.