A Study Comparing Tapinarof Cream 1% and Vtama® Cream 1% in the Treatment of Plaque Psoriasis.
NCT07546214 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 575
Last updated 2026-04-22
Summary
To demonstrate therapeutic equivalence and safety of Tapinarof Cream, 1% (Sun pharma Canada, Inc.) and Vtama® (Tapinarof) Cream, 1% in the treatment of plaque psoriasis.
Conditions
Interventions
- DRUG
-
Tapinarof Cream, 1%
The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days.
- DRUG
-
Vtama® (Tapinarof) Cream, 1%
The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days.
- DRUG
-
Placebo Control
The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days.
Sponsors & Collaborators
-
Sun Pharmaceutical Industries, Inc.
lead INDUSTRY
Principal Investigators
-
Natalie Yantovskiy · Sun Pharmaceuticals Industries, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-10-13
- Primary Completion
- 2026-03-18
- Completion
- 2026-03-18
- FDA Drug
- Yes
Countries
- United States
Study Locations
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