Enstilar® Foam in the Treatment of Chronic Plaque Psoriasis in Patients With Skin of Color
NCT03506477 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2021-01-20
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.
Conditions
Interventions
- DRUG
-
Enstilar® foam
for 4 weeks
- DRUG
-
Vehicle foam
for 4 weeks
Sponsors & Collaborators
-
Icahn School of Medicine at Mount Sinai
lead OTHER
Principal Investigators
-
Andrew Alexis, MD, MPH · Icahn School of Medicine at Mount Sinai
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-05-21
- Primary Completion
- 2019-09-25
- Completion
- 2019-09-25
- FDA Drug
- Yes
Countries
- United States
Study Locations
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