Atopic Dermatitis Clinical Trial Representation: Addressing Historical Gaps

EP: 1.Understanding Atopic Dermatitis as an Immune-Mediated Disease

EP: 2.Bridging the Gaps: Health Care Professional Knowledge Gaps in AD Pathophysiology

EP: 3.Beyond the Itch: The Full Spectrum of AD Symptoms and Their Impact on Patients

EP: 4.Recognizing AD Across All Skin Tones

EP: 5.Diagnostic Challenges and Patient Education Across Skin Tones

EP: 6.Biologic Therapy Decision-Making and Monitoring in AD

EP: 7.Access, Adaptation, and Cost-Effectiveness in AD Treatment

EP: 8.Empowering Health Care Professionals: Training and Resources for Diverse AD Care

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EP: 9.Atopic Dermatitis Clinical Trial Representation: Addressing Historical Gaps

EP: 10.Modern Clinical Trials: ADmirable and DISCOVER Data Insights for a Diverse Patient Population

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Clinical trials in atopic dermatitis have historically underrepresented patients with darker skin tones, creating significant gaps in understanding treatment efficacy and safety across diverse populations. This underrepresentation has limited researchers’ ability to answer critical questions about variations in safety and efficacy profiles, differences in baseline characteristics and comorbidities, biomarker variations, and quality-of-life impacts across racial and ethnic groups. The lack of diverse representation has particularly hindered understanding of postinflammatory hyperpigmentation effects and other considerations specific to patients with skin of color.

The implications of this underrepresentation extend beyond academic interest to real-world clinical practice, where providers need confidence in treatment recommendations for their diverse patient populations. Without adequate clinical trial data reflecting the demographics of actual patient populations, clinicians have been forced to extrapolate efficacy and safety data from study participants with lighter skin tones to their patients with darker skin tones.

Andrew Alexis, MD, MPH, notes that the field has reached an “inflection point” with newer clinical trials specifically designed to include adequate representation of patients with skin of color. This shift represents a crucial advancement in dermatologic research methodology and promises to provide the evidence base necessary for confident treatment recommendations across all patient populations. The movement toward more inclusive clinical trials reflect growing recognition that medication responses may vary across different populations and that representative data are essential for equitable health care delivery.