NCT07469228

A Study Comparing Tretinoin Gel Microsphere, 0.04% and RETIN-A MICRO ® Gel Microsphere, 0.04% in the Treatment of Acne Vulgaris

A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study, Comparing Tretinoin Gel Microsphere, 0.04% (Sun Pharmaceutical Industries, Inc.) and RETIN-A MICRO ® (Tretinoin) Gel Microsphere, 0.04% (Reference Listed Drug) in the Treatment of Acne Vulgaris.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1,043 (actual)
• Sponsor: Sun Pharmaceutical Industries, Inc. · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Accepted

Summary

To demonstrate the efficacy, therapeutic equivalence and safety of tretinoin gel microsphere, 0.04% (Sun Pharmaceutical Industries, Inc.) and RETIN-A MICRO ® (tretinoin) gel microsphere, 0.04% (Reference Listed Drug) in the treatment of acne vulgaris.

Detailed description

A multi-center, double-blind, randomized, placebo-controlled, parallel-group study, comparing Tretinoin Gel Microsphere, 0.04% (Sun Pharmaceutical Industries, Inc.) and RETIN-A MICRO ® (Tretinoin) Gel Microsphere, 0.04% (Reference Listed Drug) in the treatment of acne vulgaris.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Tretinoin Gel Microsphere, 0.04%	The investigational product will be applied topically to the affected areas of the face lightly once daily at bedtime, avoiding the eyes, mouth, and other mucous membranes for 84 consecutive days.
DRUG	RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.04%	The investigational product will be applied topically to the affected areas of the face lightly once daily at bedtime, avoiding the eyes, mouth, and other mucous membranes for 84 consecutive days.
DRUG	Placebo Control	The investigational product will be applied topically to the affected areas of the face lightly once daily at bedtime, avoiding the eyes, mouth, and other mucous membranes for 84 consecutive days.

Timeline

• Start date: 2025-08-04
• Primary completion: 2025-12-15
• Completion: 2025-12-15
• First posted: 2026-03-13
• Last updated: 2026-03-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study