Daily Literature Update
Improving Diversity in a Novel Psoriasis Study: VISIBLE as a Framework for Clinical Trial Quality Improvement
Alexis A, McMichael A, Vashi N, et al. Improving Diversity in a Novel Psoriasis Study: VISIBLE as a Framework for Clinical Trial Quality Improvement. JAMA Dermatol. 2025;161(3):256-264. PMID: 39661358.
Introduction
VISIBLE addresses longstanding underrepresentation of skin of color populations in psoriasis clinical trials through innovative recruitment strategies.
Study Type: Randomized clinical trial with diversity-focused QI assessment
Population: 211 diverse participants with moderate-severe plaque psoriasis
Intervention: Guselkumab efficacy and safety evaluation
Outcomes: Recruitment speed, retention, diversity, clinical and biomarker data
- Enrollment 7x faster than historical psoriasis trials
- 100% non-White participants; >50% skin tones Fitzpatrick IV-VI
- Broadened inclusion using colorimetry and self-reported race/ethnicity
- Culturally competent recruitment enhanced retention and data quality
Context & Related Research
- Alexis et al., 2025: Large guselkumab trial confirming efficacy across all skin tones with rapid skin clearance (PMID:40560559), supporting diversity inclusion.
- Bhutani et al., 2025: Phase 3b study with culturally sensitive recruitment and sustained QoL benefits in SoC cohorts (PMID:36012356).
- Ritchlin et al., 2024: Psoriatic arthritis RCT showing durable control with guselkumab but lacking explicit diversity focus (PMID:38844682).
Clinical Implications
- Implement dual measures (colorimetry plus self-report) to maximize SoC inclusion
- Prioritize cultural competency training and diverse staff for recruitment success
- Ensure clinical trials collect SoC-relevant biomarkers and patient-reported outcomes
Strengths & Limitations
| Strengths | Limitations |
|---|---|
| Multifaceted diversity strategies embedded in RCT design | Sample size (211) small relative to broader epidemiology |
| Comprehensive demographic and objective skin tone assessment | Short enrollment duration limits long-term retention insights |
| Retention via culturally tailored patient communications and training | Focused on psoriasis; limited data on psoriatic arthritis diversity |
Conclusion
The VISIBLE trial demonstrates that intentional, multifaceted strategies can substantially enhance diversity in psoriasis clinical research, providing a replicable model to advance equity and quality in dermatologic clinical trials.
Listen to the Podcast
A short discussion of today’s highlight.
Future Directions
Further research should evaluate long-term guselkumab safety in diverse psoriatic arthritis populations and investigate genetic/biomarker variations related to race and ethnicity.
