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

January 2025 | Volume 24 | Issue 1 | 8379 | Copyright © January 2025


Published online December 10, 2024

doi:10.36849/JDD.8379

Jennifer Y. Wang BAa,b, Kayla Zafar BAb,c, David Bitterman BAb,d, Paras Patel BAb,e, Margaret Kabakova BSa,b, Marc Cohen MDa, Jared Jagdeo MD MSa,b

aDepartment of Dermatology, State University of New York, Downstate Health Sciences University, Brooklyn, NY
bDermatology Service, Veterans Affairs New York Harbor Healthcare System - Brooklyn Campus, Brooklyn, NY
cSt. George’s University School of Medicine, Grenada, West Indies
dNew York Medical College, Valhalla, NY
eRowan University School of Osteopathic Medicine, Stratford, NJ

Abstract
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): doi:10.36849/JDD.8379

INTRODUCTION

Melasma, a symmetric pigmentary disorder, develops primarily on the face.1 Melasma typically presents as light brown to dark brown macules and patches on the forehead, malar region, and chin.1 Melasma is more prevalent in women and individuals with darker skin tones.1 Melasma is attributed to multiple etiologies, including ultraviolet (UV) sun exposure, hormonal influences, pregnancy, cosmetics, birth control, and antiseizure or phototoxic drugs.1-3 Although the precise age of onset varies, melasma generally occurs between 20 to 30 years of age.3 The global prevalence worldwide is estimated to be around 1%, while in higher-risk populations, the prevalence has been found to range from 9% to 50%.2 Melasma not only leads to considerable psychological and emotional distress but also significantly affects a patient’s quality of life.4,5 This impact is particularly pronounced in patients with skin of color, who experience a higher frequency of melasma and greater associated morbidity.4,5

The prevalence of melasma varies by race, and existing data on melasma prevalence is often limited to the demographics of specific locations where studies are performed. The prevalence of melasma in Latino populations ranges from 8.2% to 8.8%, while an Arab-American population in Michigan showed a 15.5% prevalence rate.6,7,8 In contrast, the prevalence of melasma was found to be 4% in a black population in Durban, South Africa.9 The prevalence of melasma was found to be 2.9% in Saudi Arabia and 1.5% in Ethiopia.10,11 The prevalence in India is as high as 41.1%.12 Asian countries such as Nepal and China also report prevalence rates of 6.8% and 13.6%, respectively.13,14

As the demographic landscape of the United States continues to diversify, with one in three Americans projected to be a race other than White by 2060, the need for inclusivity in dermatologic research becomes increasingly necessary.15 Racial minorities are often underrepresented in dermatology clinical trials, including trials involving hidradenitis suppurativa (HS), nail psoriasis, psoriatic arthritis, and laser treatments for scars.16-20 There is currently a gap in knowledge pertaining to patient representation in melasma clinical trials. Given the documented underrepresentation of skin of color participants in dermatologic clinical trials and the higher prevalence of melasma within these populations, we aim to analyze gender, racial, and Fitzpatrick skin type (FST) representation in melasma clinical trials.16-20