Psoriasis Study Identifies Strategies for Enrolling More Patients with Skin of Color

Andrew F. Alexis, MD, MPH

Credit: Weill Cornell Medicine

The rapid level of enrollment in a recent psoriasis study highlights that intentional and strategic approaches to trial design and conduct can lead to greater participation and retention of participants with skin of color.¹

This ad hoc quality improvement assessment of the VISIBLE study was authored in part by Andrew Alexis, MD, MPH, of Weill Cornell Medicine’s department of dermatology in New York. Alexis et al. sought to explore whether an innovative trial design can lead to the removal of barriers to recruiting and retaining individuals with psoriasis and skin of color.

The investigators of this assessment further noted that the demographic composition of most prior dermatology research was not reflective of the US’s diverse population, as well as the country’s disease epidemiology.²

“This report discusses innovative strategies used in the ongoing VISIBLE trial to overcome barriers to recruiting and retaining participants with [skin of color] and to address the unmet needs of diverse populations with [skin of color],” Alexis and colleagues wrote.¹

Trial Design Details

The Varying Skin Tones in Body and Scalp Psoriasis: Guselkumab Efficacy and Safety (VISIBLE) trial was described by the investigative team as a landmark in clinical research as the first large-scale, double-blind, randomized, placebo-controlled analysis specifically designed to look into psoriasis and treatment outcomes across all skin tones in those with skin of color.

The study was designed to assess guselkumab’s efficacy and safety. A variety of objective assessments in this ad hoc assessment of the VISIBLE study were used, as well as patient-reported parameters, with investigators examining participant recruitment and retention strategies used in the trial.

VISIBLE enrolled a total of 211 subjects, with the group’s mean age being 43 years, 36% of the population being female, and 64% being male. The study looked at individuals with skin of color and moderate-to-severe plaque psoriasis between August 2022 - March 2023.

The research team implemented both objective methods, such as colorimetry to determine subjects’ Fitzpatrick skin types, and self-reported data. The VISIBLE study achieved noteworthy results, with the investigators highlighting that there was an enrollment rate approximately 7 times faster than historical psoriasis studies.

Participants were asked by the team to identify their own racial and ethnic backgrounds. The research team noted that their representation was 29.9% Asian, 0.5% American Indian or Alaska Native, 11.4% Black, 6.2% Middle Eastern, 44.5% Hispanic or Latino, 0.5% Pacific Islander or Native Hawaiian, 5.7% multiracial, and 1.4% those labeled as other.

Findings

All participants identified as a race or ethnicity other than White, the investigators noted, and more than half of them had skin tones classified within the darker range of the Fitzpatrick scale (types IV-VI).

The VISIBLE analysis introduced several innovative approaches: assessing genetic and comorbidity biomarkers specific to populations with diverse skin types, tracking any post-inflammatory changes in pigment with combined objective and subjective evaluations, and prioritizing selection of sites based on diverse demographics and investigator expertise.

Additionally, the study also incorporated trainings in cultural competency with the aim of enhancing recruitment and retention. They also gathered patient-reported data in participants’ native languages and carried out blinded central reviews with the aim of accuracy and consistency in their tests of efficacy for those with skin of color and psoriasis.

These strategies were said to have collectively enhanced the trial’s reliability, inclusivity, and relevance for addressing psoriasis in diverse populations.

“Data from VISIBLE will help address important clinical care gaps and inform best practices to drive inclusive clinical research in dermatology,” they concluded.¹

References

1. ^{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. Published online December 11, 2024. doi:10.1001/jamadermatol.2024.5103.}
2. ^{Chen V, Akhtar S, Zheng C, Kumaresan V, Nouri K. Assessment of changes in diversity in dermatology clinical trials between 2010-2015 and 2015-2020: a systematic review. JAMA Dermatol. 2022;158(3):288-292. doi:10.1001/jamadermatol.2021.5596.}