The VISIBLE (Varying Skin Tones in Body and Scalp Psoriasis: Guselkumab Efficacy and Safety) trial has demonstrated that intentional and strategic approaches to trial design can significantly enhance the participation and retention of individuals with skin of color (SoC) in psoriasis research. This is crucial as clinical trials have historically struggled to reflect the diversity of the U.S. population, leading to critical data gaps for conditions like psoriasis that manifest differently across various skin types, races, ethnicities, and socioeconomic backgrounds. The ad hoc quality improvement assessment study is published in JAMA Dermatology.
Innovative Strategies for Inclusivity
The VISIBLE trial incorporated several innovative strategies to overcome barriers to recruiting and retaining participants with SoC. These included:
- Broadening Inclusivity: Allowing participants to self-identify their race and ethnicity, alongside objective measures of skin tone using colorimetry and spectrophotometry.
- Enhanced Photography: Implementing enhanced photography with central review to ensure consistent evaluations across the spectrum of skin tones.
- Demographic-Driven Site Selection: Prioritizing sites with diverse investigators and staff.
- Cultural Competency Training: Providing cultural competency training to investigators and staff.
- Patient-Reported Outcomes: Collecting patient-reported outcomes in participants’ primary languages.
- Blinded Central Reviews: Conducting periodic blinded central reviews of efficacy scoring.
Rapid Enrollment and Diverse Representation
The trial, conducted from August 2022 to March 2023, successfully enrolled and randomized 211 participants. The mean age of participants was 43 years, with 36% females and 64% males. Participants self-identified across a diverse range of racial and ethnic backgrounds, including 29.9% Asian, 44.5% Hispanic/Latino, 11.4% Black, and smaller percentages of American Indian/Alaska Native, Middle Eastern, Pacific Islander/Native Hawaiian, multiracial, and other groups. All participants identified as a race or ethnicity other than White, and over 50% had skin tones in the darker half of the Fitzpatrick skin type spectrum (types IV-VI).
Notably, participant enrollment occurred approximately seven times faster than anticipated, a significant improvement compared to historical recruitment data for psoriasis studies. This rapid enrollment underscores the effectiveness of the strategies implemented to enhance diversity.
Addressing Clinical Care Gaps
The data from VISIBLE is expected to address important clinical care gaps and inform best practices to drive inclusive clinical research in dermatology. By including a representative demographic profile for psoriasis in SoC, the trial sets the stage for future studies to build on its methods and findings.
Andrew F. Alexis, MD, MPH, FAAD, of Weill Cornell Medicine, noted that the study offers an opportunity to better understand clinical features and their progression over time in patients with skin of color, filling important educational and data gaps for this historically understudied patient population.
Limitations and Future Directions
The researchers acknowledged several limitations, including the novelty of using colorimetry in psoriasis trials, which posed challenges in data interpretation. Additionally, the lack of enrollment quotas by race and ethnicity required grouping some self-identified racial and ethnic categories for statistical analysis. The relatively small size of the trial compared to most psoriasis trials may also limit the generalizability of findings.
Despite these limitations, the VISIBLE trial represents a significant step forward in promoting diversity and inclusion in psoriasis research, providing a framework for future studies to address the unmet needs of diverse populations with skin of color.
