NCT06742957

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

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site, Clinical Study to Evaluate the Therapeutic Equivalence of Tapinarof Cream 1% (Teva Pharmaceuticals, Inc.) With VTAMA® Tapinarof (Tapinarof) Cream 1% (Dermavant Sciences, Inc.) in Adult Patients With Plaque Psoriasis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 560 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

To compare the safety of Test, Reference, and Placebo treatments in patients with Plaque Psoriasis. Patients in this randomized, double-blind, three-arm, placebo controlled, parallel-design, multi-site study will be randomly assigned in a 2:2:1 ratio to treatment with the test product, reference product or placebo control, respectively.

Conditions

• Plaque Type Psorisis

Interventions

Type	Name	Description
DRUG	Tapinarof Cream 1%	Cream
DRUG	VTAMA®	Cream
DRUG	Placebo	Cream

Timeline

• Start date: 2024-12-17
• Primary completion: 2025-10-07
• Completion: 2025-11-12
• First posted: 2024-12-19
• Last updated: 2025-12-17

Locations

26 sites across 1 country: United States

Regulatory

• FDA-regulated drug study