NCT04883736

A Study Comparing Tretinoin Gel Microsphere, 0.1% and RETIN-A MICRO ® Gel Microsphere, 0.1% in the Treatment of Acne Vulgaris

A Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-Group Study Comparing Tretinoin Gel Microsphere, 0.1% (Taro Pharmaceuticals U.S.A, Inc.) to RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.1% (Valeant) and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 973 (actual)
• Sponsor: Sun Pharmaceutical Industries, Inc. · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Accepted

Summary

To demonstrate the therapeutic equivalence and safety of Tretinoin Gel Microsphere, 0.1% (Taro Pharmaceuticals U.S.A, Inc.) and RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.1% (Valeant) in the treatment of acne vulgaris.

Detailed description

A multi-center, double-blind, randomized, placebo controlled, parallel-group study, comparing Tretinoin Gel Microsphere, 0.1% (Taro Pharmaceuticals U.S.A, Inc.) and RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.1% (Valeant) in the treatment of acne vulgaris.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Tretinoin Gel Microsphere, 0.1%	The study medication will be self-applied topically, on the affected areas of the face lightly, once daily in the evening, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.
DRUG	RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.1%	The study medication will be self-applied topically, on the affected areas of the face lightly, once daily in the evening, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.
DRUG	Placebo Control	The study medication will be self-applied topically, on the affected areas of the face lightly, once daily in the evening, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.

Timeline

• Start date: 2020-08-31
• Primary completion: 2021-04-16
• Completion: 2021-04-16
• First posted: 2021-05-12
• Last updated: 2021-05-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study