NCT05550337

Study Comparing Trifarotene Cream, 0.005% To AKLIEF ® (Trifarotene 0.005% Cream) In The Treatment Of Acne Vulgaris

A MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, THREE-ARM, PLACEBO CONTROLLED, PARALLEL-DESIGN GROUP STUDY TO EVALUATE THE THERAPEUTIC EQUIVALENCE COMPARING TRIFAROTENE CREAM, 0.005% (TEVA PHARMACEUTICALS, INC. TO AKLIEF ® (TRIFAROTENE 0.005% CREAM) (GALDERMA LABORATORIES, L.P., USA), IN THE TREATMENT OF ACNE VULGARIS

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 807 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Accepted

Summary

To compare the safety and efficacy of the test (Trifarotene 0.005% cream), placebo (vehicle cream) and reference AKLIEF® (Trifarotene 0.005% cream) treatments to demonstrate clinical equivalence in subjects with acne vulgaris.

Detailed description

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

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Trifarotene 0.005 % Topical Cream	Cream
DRUG	AKLIEF®	Cream
DRUG	Placebo	Cream

Timeline

• Start date: 2022-09-19
• Primary completion: 2023-05-09
• Completion: 2023-05-09
• First posted: 2022-09-22
• Last updated: 2024-09-26
• Results posted: 2024-09-26

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study