Racial and Ethnic Representation in Atopic Dermatitis Clinical Trials

April 2025 | Volume 24 | Issue 4 | 360 | Copyright © April 2025


Published online March 14, 2025

doi:10.36849/JDD.8705

Margaret Kabakova BSa,b, Jennifer Y. Wang BAa,b, Paras Patel BAb,c, Kayla Zafar BAb,d, David Bitterman BAb,e, 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
cRowan University School of Osteopathic Medicine, Stratford, NJ
dSt. George's University School of Medicine, Grenada, West Indies
eNew York Medical College, Valhalla, NY

Abstract


Atopic dermatitis (AD) is a chronic inflammatory skin disorder afflicting approximately 31.6 million people in the United States, with a disproportionate impact on racial and ethnic minorities who often experience greater disease severity. This study aims to analyze racial and ethnic representation in recent atopic dermatitis clinical trials. A search on clinicaltrials.gov identified 73 completed AD trials with results available from January 1, 2019, to May 13, 2024, and out of these, 68 trials involving 20,679 patients provided race and ethnicity data. Out of all clinical trial participants, 65.4% identified as White, 17.3% identified as Asian, 13.4% identified as Black or African American, 0.5% identified as American Indian or Alaskan Native, 0.4% identified as Native Hawaiian or Pacific Islander, and 1.3% identified as more than one race. Hispanic or Latino participants comprised 10.8% of the clinical trial population. This study highlights an increasing trend in the inclusion of African American/Black and Asian populations in AD clinical trials; however, Hispanic participants remain notably underrepresented despite increased ethnicity reporting. These disparities emphasize the necessity of diverse representation in AD clinical trials to ensure equitable treatment outcomes, especially given the higher disease prevalence in skin of color groups. Achieving equitable representation will improve the generalizability of trial results, enhance treatment access, and reduce health inequities. Greater inclusivity in AD clinical trials is crucial for understanding the safety, efficacy, and side effects of treatments across diverse populations and should be a cornerstone of dermatologic clinical research.

J Drugs Dermatol. 2025;24(4):360-364. doi:10.36849/JDD.8705

INTRODUCTION

Atopic dermatitis (AD) is the most common chronic inflammatory skin disorder globally, with an estimated prevalence of 31.6 million people in the United States (US) alone.1,2 AD characteristically presents with dry and itchy skin prone to infection.3 Although the pathophysiology of AD is not fully understood, it is well established that genetic predisposition, skin barrier dysfunction, immune dysregulation, and environmental factors contribute to AD pathogenesis.4 With acute disease flares often featuring intensely pruritic papules, exudation, and peeling of the skin, AD is the primary contributor to skin-related disability.5,6 Prevalent in both children and adults, 80% of AD sufferers experience disease onset before the age of 6, with African American/Black and Hispanic children typically experiencing more severe disease than White children.7,8 Furthermore, there is a known higher disease prevalence among Black or African Americans compared to Whites, reported in 2019 as 19.3% vs 16.1% in children and 4.4% vs 2.1% in adults.9 AD can lead to considerable psychological and emotional distress, significantly affecting self-esteem, quality of life, and career choices, especially in patients of color due to higher disease prevalence and severity.7,9,10

The growing diversity in the US underscores the crucial need for inclusivity in dermatologic research, with the US Census Bureau projecting that approximately half of the US population will be comprised of Hispanic, African American/Black, or Asian individuals by 2050.11 Racial minorities are frequently underrepresented in dermatology clinical trials, including those focused on conditions such as acne, alopecia, hidradenitis suppurativa, nail psoriasis, psoriatic arthritis, and the majority of laser therapy applications.12-17 A gap exists in the understanding of patient representation in atopic dermatitis clinical trials. Due to the well-documented underrepresentation of participants with skin of color in dermatologic studies and the higher incidence of atopic dermatitis among these groups, our goal is to assess racial and ethnic representation in clinical trials for AD.
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