NCT03506477

Enstilar® Foam in the Treatment of Chronic Plaque Psoriasis in Patients With Skin of Color

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 skin of color (FST IV-VI). This study will also evaluate the degree of erythema versus hyperpigmentation in psoriasis plaques in skin of color (and its change with Enstilar ® treatment) as well as the effect of Enstilar ® on post-inflammatory hyperpigmentation and quality of life.

Detailed description

Psoriasis is a chronic inflammatory disorder primarily affecting the skin and joints. This condition occurs in different ethnic groups worldwide with varying prevalence. There are notable differences in psoriasis presentation in skin of color groups. Black patients with psoriasis tend to have less erythema, increased risk of pigmentation, thicker plaques, more scaling, and greater body involvement as compared to white patients. The resolution of psoriasis lesions in darker skin types is associated with a higher rate of dyspigmentation (both hyper- and hypo-pigmentation), which may be more bothersome to patients than the psoriasis itself. Further, several studies have shown that psoriasis is associated with greater psychological impact and worse quality of life in non-whites with psoriasis compared to whites. Unique issues in skin of color populations make studies dedicated to darker skin types essential for the treatment of psoriasis in these populations. This study will evaluate the efficacy of Enstilar® foam, a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%, in the treatment of psoriasis vulgaris in darker skin types. This study will also evaluate the degree of erythema versus hyperpigmentation in psoriasis plaques as well as the effect of Enstilar ® on post-inflammatory hyperpigmentation and quality of life in skin of color.

Conditions

• Plaque Psoriasis
• Psoriasis

Interventions

Type	Name	Description
DRUG	Enstilar® foam	for 4 weeks
DRUG	Vehicle foam	for 4 weeks

Timeline

• Start date: 2018-05-21
• Primary completion: 2019-09-25
• Completion: 2019-09-25
• First posted: 2018-04-24
• Last updated: 2021-01-20
• Results posted: 2021-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study