Abstract

Importance:  Diverse racial and ethnic representation in clinical trials has been limited, not representative of the US population, and the subject of pending US Food and Drug Administration guidance. Psoriasis presentation and disease burden can vary by skin pigmentation, race and ethnicity, and socioeconomic differences. Overall, there are limited primary data on clinical response, genetics, and quality of life in populations with psoriasis and skin of color (SoC). The Varying Skin Tones in Body and Scalp Psoriasis: Guselkumab Efficacy and Safety trial (VISIBLE) is underway and uses strategies aimed at addressing this persistent gap.

Objective:  To assess the innovative strategies used in the VISIBLE trial to recruit and retain diverse participants in a randomized clinical trial of psoriasis in participants with SoC.

Design, Setting, and Participants:  This was an ad hoc quality improvement assessment of participant recruitment and retention approaches used by the VISIBLE trial. VISIBLE enrolled and randomized 211 participants (mean [SD] age, 43 [13] years; 75 females [36%] and 136 males [64%]) with SoC and moderate to severe plaque psoriasis from August 2022 to March 2023 to evaluate guselkumab treatment. The self-identified race and ethnicity of the participants was: 1 American Indian/Alaska Native (0.5%), 63 Asian (29.9%), 24 Black (11.4%), 94 Hispanic/Latino (44.5%), 13 Middle Eastern (6.2%), 1 Pacific Islander/Native Hawaiian (0.5%), 12 multiracial (5.7%), and 3 of other race and/or ethnicity (1.4%). Using a combination of objective (colorimetry to determine Fitzpatrick skin type) and self-reported (race and ethnicity consistent with SoC) parameters, VISIBLE sought to broaden inclusion of participants from various backgrounds.

Results: Observed improvements were that participant enrollment occurred approximately 7 times faster than anticipated (vs historical recruitment data for psoriasis studies); 211 participants (100%) self-identified themselves as a race or ethnicity other than White; and more than 50% had skin tone in the darker half of the Fitzpatrick skin type spectrum (type IV-VI). Innovations implemented by VISIBLE were (1) assessment of the natural history of postinflammatory pigment alteration and improvements over time using combined objective colorimetry and clinician- and patient-reported outcomes; (2) evaluation of genetic and comorbidity biomarkers relevant to participants with SoC; (3) a diverse demographic-driven approach to site selection (emphasizing investigator and staff diversity and experience with populations with SoC); (4) provision of cultural competency training to enhance participant enrollment and retention; (5) collection of patient-reported outcomes data in participants’ primary language; and (6) periodic, blinded central review and feedback on investigator efficacy scoring to promote consistency and accuracy in evaluating psoriasis in participants with SoC.

Enhancing Evaluation of Psoriasis Severity and Signs Across the Skin-Tone Spectrum:   Although the visual appearance of psoriasis may be affected by constitutive skin pigmentation,^8,27 most medical resources contain images of individuals with lighter skin and plaques characterized by salmon-pink coloration and silvery scale.^8,28 The lack of representative psoriasis images in darker skin types may affect whether individuals perceive that they have psoriasis and should seek medical care, as well as clinicians’ ability to recognize psoriasis, accurately determine disease severity, and evaluate treatment response in people with SoC. To promote consistent evaluations across VISIBLE investigators and study sites, dedicated training modules developed by experts in SoC (including A. A.), which included sample images depicting the entire range of psoriasis severity across the spectrum of skin tones (eg, lightly, intermediately, or darkly pigmented skin), were used along with a quiz to confirm investigator comprehension of ratings across skin tones. Additionally, a blinded panel of experts in SoC compared participant photographs and investigator ratings throughout the trial to ensure consistent assessment, and provided feedback and additional training, as needed.

Because erythema has a varied and nuanced appearance on melanin-rich skin,^8 ,29 psoriasis severity is more likely to be underestimated in individuals with SoC. Cross-polarized photography has been used to successfully assess changes in various inflammatory dermatologic diseases.²⁹ To support objective evaluation of disease severity in participants with SoC, clinical photographs are obtained at regular intervals, using both standard and cross-polarized lighting (Figure 3). In addition to decreasing glare and enhancing erythema, cross-polarized photography increases contrast between lesions and underlying skin, which is particularly useful for differentiating erythema from hyperpigmentation in individuals with SoC.²⁹ At the end of the study, VISIBLE will have approximately 20 000 standard and cross-polarized clinical images of psoriasis across diverse skin tones that can be used for both patient and clinician education.

Conclusions and Relevance:  VISIBLE is a unique study focused on addressing important knowledge and data gaps in populations of patients with psoriasis and SoC, with the goal of generating data to help improve clinical care and inform future best practices in diversity within dermatology research. The rapid study enrollment demonstrates that intentional and strategic approaches to clinical trial design and conduct can speed recruitment and bolster participation and retention of diverse populations in a dermatologic setting.