Racial and Ethnic Diversity in Vitiligo Clinical Trials: A Retrospective Cross-Sectional Study Assessing Demographic Reporting of Participants

July 2024 | Volume 23 | Issue 7 | e164 | Copyright © July 2024


Published online June 18, 2024

Swathi Holla MSa, Arielle Carolina Mora Hurtado BSb, Sarah Gonzalez MDc, Rohit Gupta MDd, Amit G. Pandya MDd,e, Nada Elbuluk MD MScf

aSchool of Medicine, Baylor College of Medicine, Houston, TX
bUniversity of Wisconsin School of Medicine and Public Health, Madison, WI
cWayne State University, School of Medicine, Detroit, MI
dDepartment of Dermatology, University of Texas Southwestern Medical Center, Dallas, TX
eDepartment of Dermatology, Palo Alto Foundation Medical Group, Sunnyvale, CA
fDepartment of Dermatology, Keck School of Medicine, University of Southern California, Los Angeles, CA

Abstract
Background: While the prevalence of vitiligo is similar across racial and ethnic groups, the effects of vitiligo vary by demographic group, culture, and skin color, with darker-skinned individuals facing greater stigma due to increased visibility of the disease. The recruitment of diverse participants that are representative of the United States (US) population is crucial to ensuring the generalizability of findings and understanding the impacts of vitiligo across diverse patient groups.  
Objectives: This study aimed to determine demographic reporting trends in US vitiligo clinical trials and to determine whether participants are representative of the US population.
Methods: A search for US vitiligo clinical trials was conducted on clinicaltrials.gov. Trials conducted between 2006 to September 5, 2023, were included if they intended to treat vitiligo, were conducted in the US, and were completed or terminated. 
Results: Of the 15 trials meeting inclusion criteria, only 60% (n=9) reported participant race/ethnicity. These 9 studies included 1,510 participants, of which only 25.43% (n=384) were non-White and 20.40% were Hispanic. There was disproportionately low representation of racial minorities, particularly Black, Native American, and Native Hawaiian groups.  
Limitations: Limitations of our study include small sample size, variations in demographic reporting between trials, and undercounting of minority groups by the US Census. 
Conclusions: Racial and ethnic minority groups remain underrepresented in US vitiligo clinical trials. Given that the impact of vitiligo can vary by the affected individual's demographic group and skin color, investigators must be intentional about including a more diverse and representative population in vitiligo clinical trials. 

J Drugs Dermatol. 2024;23(7):e164-e166. doi:10.36849/JDD.8117e

INTRODUCTION

Vitiligo is a chronic, depigmenting, autoimmune skin condition with a similar prevalence across all racial and ethnic groups.1 Despite this equal prevalence, the degree to which quality of life is impaired by vitiligo has been shown to vary by the affected individual's race, ethnicity, culture, and skin color.1,2 Darker-skinned individuals affected by vitiligo may experience more concern and stigma regarding their appearance due to the increased visibility of the condition.1 Studies have found that the stigma surrounding vitiligo varies by the affected individual's cultural background and level of assimilation into Western culture.2 Given these differences, recruiting racially and ethnically diverse participants who are representative of the United States (US) population is crucial to ensuring the generalizability of vitiligo research. However, it has been demonstrated that racial and ethnic minority groups are underrepresented in dermatology research studies.3 

A previous analysis of vitiligo studies found underreporting of demographic data and underrepresentation of participants with Fitzpatrick skin types V-VI.4 These issues are prevalent across dermatology research for most disorders.5 A review of clinical trials for acne, atopic dermatitis, and psoriasis found that less than 25% of trials reported both participant race and ethnicity. Furthermore, white participants were overrepresented, constituting 77.5% of total participants.5 To address demographic underreporting, the NIH mandated that NIH-funded trials report participant demographics on clinicaltrials.gov in 2017.5 This study aims to determine the racial/ethnic demographic 
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