NCT06733402

A Study Comparing Trifarotene Cream 0.005% to AKLIEF® CREAM (US REFERENCE LISTED DRUG), AKLIEF™ CREAM (CANADIAN REFERENCE PRODUCT) in the Treatment of Acne Vulgaris

A Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-group Study, Comparing Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A, Inc.) to Aklief® Cream (US REFERENCE LISTED DRUG), Aklief Cream (REFERENCE PRODUCT) and Each Active Treatment to a Placebo Control in the Treatment of Acne Vulgaris.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1,000 (actual)
• Sponsor: Sun Pharmaceutical Industries, Inc. · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate the efficacy, therapeutic equivalence and safety of Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A., Inc.) and US Reference Listed Drug, Canadian Reference Product over the placebo control in the treatment of acne vulgaris.

Detailed description

A multi-center, double-blind, randomized, placebo-controlled, parallel-group study, comparing comparing Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A, Inc.) to Aklief® Cream (US REFERENCE LISTED DRUG), Aklief Cream (REFERENCE PRODUCT) and each active treatment to a placebo control in the treatment of acne vulgaris.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Trifarotene Cream 0.005%	A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.
DRUG	AKLIEF® Cream (Trifarotene 0.005%) US REFERENCE LISTED DRUG	A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.
DRUG	AKLIEF® Cream (Trifarotene 50 mcg/g) CANADIAN REFERENCE PRODUCT	A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.
DRUG	Placebo	A thin layer of the investigational product will be self-applied to the affected areas of the face once daily at bedtime.

Timeline

• Start date: 2024-06-20
• Primary completion: 2024-06-20
• Completion: 2024-11-09
• First posted: 2024-12-13
• Last updated: 2024-12-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study