drugset / Trial / NCT07469228

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

NCT07469228

Phase 1 Completed 1043 enrolled Sun Pharmaceutical Industries, Inc.
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2025-08-04
Primary completion
2025-12-15
Completion
2025-12-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Tretinoin Small molecule 0.04 % Topical

Indications