Gender, Racial, and Fitzpatrick Skin Type Representation in Melasma Clinical Trials

Melasma, a symmetric pigmentary disorder, is more prevalent in women and individuals with darker skin tones. Despite its global prevalence, there is a notable gap in the understanding of gender, racial, and Fitzpatrick skin type (FST) representation in melasma clinical trials. We conducted a comprehensive search of the United States (US) National Library of Medicine clinical trials database (ClinicalTrials.gov) on March 2nd, 2024, to identify melasma clinical trials. The aim of this study was to assess the demographic representation of participants enrolled in melasma clinical trials. Out of 56 trials identified, 19 met the inclusion criteria, comprising 614 patients. Our analysis revealed a predominant representation of female patients (96.58%) and a diverse representation of racial and ethnic groups, with a majority of Hispanic or Latino patients (43.10%), followed by Asian (23.71%), White (15.52%), and Black or African American patients (14.66%). Fitzpatrick skin types III and IV were most common among trial participants, totaling over 75% of trial participants. The identified gender, racial, and FST representation suggest a deliberate effort towards more inclusive research practices in dermatology. This trend towards inclusivity sets a valuable precedent for improving representation in research for other dermatological conditions that disproportionately impact skin of color patients. J Drugs Dermatol. 2025;24(1):19-22. doi:10.36849/JDD.8379.