Last updated on November 2019

A double-blinded, placebo-controlled study to evaluate the tolerability and efficacy of Enstilar® (calcipotriene and betamethasone dipropionate) Foam in the treatment of chronic plaque psoriasis in patients with skin of color (Fitzpatrick skin phototypes IV-VI)


Brief description of study

Psoriasis is a chronic inflammatory disorder primarily affecting the skin and joints that occurs in diverse ethnic groups worldwide.  There is paucity of data on the use of topical medications in dark-skinned individuals. Unique issues in skin of color (SOC) populations, including increased risk of dyspigmentation (hyperpigmentation and hypopigmentation), make studies dedicated to darker skin types essential for treatment of psoriasis in these populations.

This will be a single-center, randomized, double-blinded, vehicle-controlled clinical study to determine the efficacy of Enstilar® foam, a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%, in the treatment of psoriasis vulgaris in SOC (FST IV-VI).  A total of 25 subjects with at least mild psoriasis (ages 18+, male and female, ≥2% body surface area involved) are expected to complete this study, which will run for a total of up to 12 weeks. 

The study consists of three periods: Screening (from 0 to 4 weeks); Double-blind, vehicle-controlled treatment period (4 weeks), and open-label treatment period (4 weeks). During the second period (double-blind, vehicle-controlled), a total of 20 subjects will be randomized to Enstilar ® and a total of 5 subjects will be randomized to vehicle. Those who meet all of the inclusion/exclusion criteria and are enrolled in the study will receive study drug (either Enstilar® or vehicle) for the entire treatment period.

Clinical Study Identifier: TX203435

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