The VISIBLE trial, a novel study addressing psoriasis in patients with skin of color (SoC), has set a new standard for diversity in dermatology clinical trials. By employing innovative strategies, the trial achieved rapid enrollment and broad representation, demonstrating how intentional trial design can overcome barriers to inclusion.
The trial enrolled 211 participants with moderate to severe plaque psoriasis from diverse racial and ethnic backgrounds, including 44.5% Hispanic/Latino, 29.9% Asian, and 11.4% Black individuals. Over half of the participants had darker skin tones (Fitzpatrick types IV–VI). Enrollment was approximately seven times faster than historical psoriasis studies, underscoring the effectiveness of the approach.
VISIBLE incorporated several groundbreaking strategies: the use of colorimetry and enhanced photography to evaluate skin pigmentation and disease severity, cultural competency training for trial staff, and collection of patient-reported outcomes in participants’ primary languages. The trial also prioritized diversity in site selection, with investigators experienced in working with SoC populations, and employed periodic blinded reviews to ensure consistent evaluation across all skin tones.
These methods not only bolstered recruitment and retention but also allowed the study to assess critical factors like post-inflammatory pigment changes, genetic biomarkers, and comorbidities specific to SoC populations.
The researchers highlighted the importance of these efforts, stating that the trial’s success “demonstrates that intentional and strategic approaches to clinical trial design can generate meaningful data for underrepresented populations.”
VISIBLE provides a framework for improving diversity in dermatology research, helping to close knowledge gaps and enhance care for patients with psoriasis and skin of color.
Reference: Alexis A et al. Improving Diversity in a Novel Psoriasis Study: VISIBLE as a Framework for Clinical Trial Quality Improvement. JAMA Dermatol. 2024; DOI:10.1001/jamadermatol.2024.5103.
Aleksandra Zurowska | AMJ
