Study Comparing Tapinarof Cream 1% To VTAMA ® (Tapinarof Cream 1%) In the Treatment of Plaque Psoriasis

Conditions

• Plaque Type Psorisis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Tapinarof Cream 1% — DRUG
  Cream
• VTAMA® — DRUG
  Cream
• Placebo — DRUG
  Cream

Study Details

To compare the safety and efficacy of the test (Tapinarof Cream 1%), placebo (vehicle cream) and reference VTAMA® (Tapinarof Cream 1%) treatments to demonstrate clinical equivalence in patients with plaque psoriasis.

Key Dates

Start date

Dec 17, 2024

Status verified

Dec 2025

Primary completion

Oct 7, 2025

Completion

Nov 12, 2025

Study Design

Enrollment

560 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Test: Tapinarof Cream 1%
  Tapinarof Cream 1%, Apply a thin layer once daily to psoriatic affected areas for 84 days.
• Active Comparator: VTAMA®
  (Tapinarof) Cream 1%, Apply a thin layer once daily to psoriatic affected areas for 84 days.
• Placebo Comparator: Vehicle Product
  Vehicle of the Test Product, Cream, Apply a thin layer once daily to psoriatic affected areas for 84 days.

Primary Outcome Measure

Primary change in the Physician Global Assessment (PGA) [ Time Frame: 12 Weeks ]

Locations (26)

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