drugset / Trial / NCT03292640

A Study of the Safety and Efficacy of DFD-03 Lotion in the Treatment of Acne Vulgaris for 12 Weeks

NCT03292640

Phase 3 Completed 547 enrolled Dr. Reddy's Laboratories Limited
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Enrollment of subjects with mild to moderate facial acne vulgaris. Co-Primary efficacy endpoints included: * Absolute change from Baseline to Week 12 in the inflammatory lesion counts on the face * Absolute change from Baseline to Week 12 in the non-inflammatory lesion counts on the face * Proportion of subjects with a clinical response of "success" at Week 12 for lesions on the face. Success based on IGA is defined as an IGA score of 0 (Clear) or 1 (Almost clear) at Week 12 with at least a 2-grade reduction from Baseline.

Timeline

Start
2017-07-06
Primary completion
2018-05-14
Completion
2018-05-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Tazarotene Small molecule 0.1 %

Indications