Efficacy and Safety of Calcipotriene/Betamethasone Dipropionate Foam in the Treatment of Psoriasis in Skin of Color

February 2023 | Volume 22 | Issue 2 | 165 | Copyright © February 2023


Published online January 27, 2023

Jacqueline Liu BSa, Ahuva Cices MDa, Bridget Kaufman MDa, Ingrid Sanabria-Gonzalez AAa, Andrew Alexis MD MPHb

aDepartment of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY
bDepartment of Dermatology, Weill Cornell Medicine, New York, NY

Abstract
Background: There is a paucity of data on usage of topical medications in patients with darker phototypes. This single-center, randomized, double-blinded, vehicle-controlled clinical study investigated the efficacy of a combination calcipotriene/betamethasone dipropionate (Cal/BD) aerosol foam 0.005%/0.064% in the treatment of psoriasis vulgaris in Fitzpatrick skin types IV to VI.
Methods: 25 adult subjects were randomized 4:1 to Cal/BD foam or foam vehicle once daily for 4 weeks followed by 4 weeks of open label treatment. From week 4 to week 8, subjects randomized to Cal/BD foam once daily switched to Cal/BD foam twice weekly for 4 weeks, while those randomized to vehicle applied Cal/BD foam once daily.
Results: At week 4, 4/19 (21%) of Cal/BD foam patients achieved clear/almost clear Investigator Global Assessment (IGA) status with ≥2 grade improvement compared with 0/5 (0%) of vehicle patients (P=0.54). 12/19 (63%) of Cal/BD foam patients achieved a 50% reduction in Psoriasis Area and Severity Index (PASI 50) at week 4, compared with 0/5 (0%) of vehicle patients (P=0.04). Mean changes in melanin index at week 4 indicate a trend toward increased pigmentation in Cal/BD foam patients and decreased pigmentation in foam vehicle patients (P=0.30). All adverse events were mild and deemed unrelated to treatment by the investigators.
Limitations: The sample size was small and underpowered to detect statistically significant changes in most endpoints.
Conclusion: Cal/BD foam was safe and well tolerated in plaque psoriasis patients with skin of color. Larger studies involving skin of color populations with psoriasis are warranted. Pigmentary changes (hyper- and hypopigmentation) in lesional skin were observed.

J Drugs Dermatol. 2023;22(2): 165-173.doi:10.36849/JDD.6910

INTRODUCTION

Psoriasis is a chronic inflammatory disorder involving the skin and joints. Although psoriasis is more prevalent in populations of European ancestry, recent data show substantial rates of psoriasis in populations with skin of color.1,2 According to data from the 2011-2014 National Health and Nutrition Examination Surveys (NHANES), a national data repository representative of the adult population in the United States, 3.6% of Caucasian, 1.5% of African American, and 1.9% of Hispanic adults between the ages of 20 and 59 years were affected by psoriasis; which is relatively unchanged from the 2009-2010 NHANES data.1 The prevalence of psoriasis in darker phototypes may be higher than estimated figures suggest given that non-white patients are more likely to have undiagnosed psoriasis.3

Classically, plaque psoriasis lesions are described as erythematous plaques with sharp borders and micaceous scale. However, psoriasis in skin of color may have morphological and clinical variations including thicker and scalier plaques, greater body surface area involvement, less conspicuous erythema, and increased risk of post-inflammatory pigment changes.4-6 Erythema is often obscured in skin of color, and can appear hyperchromic or violaceous.5,7 Furthermore, even after resolution of lesions, patients with darker skin types often have dyspigmentation that can be at least as bothersome as the original psoriatic lesions.7,8 Notably, psoriasis in skin of color has been associated with greater psychological impact and worse quality of life (QOL), demonstrated by higher Dermatology Life Quality Index (DLQI) scores in Black and Hispanic populations.6,7,9,10

Despite differences in the presentation and sequelae of psoriasis between diverse ethnic groups, there is a paucity of data on the use of topical medications in patients with darker phototypes.11,12 Phase II and III clinical trials with combined calcipotriene and betamethasone dipropionate (Cal/BD) 0.005%/0.064% aerosol foam showed efficacy in the treatment of mild, moderate, and severe plaque psoriasis and improved QOL with once daily use for 4 weeks.13-15 In the phase III PSO-ABLE study comparing Cal/BD aerosol foam with Cal/BD gel, 37.8% of 180 aerosol foam-treated patients achieved treatment success at week 4 according to the Physician's Global