drugset / Trial / NCT03290027

A Study of the Safety and Efficacy of DFD-03 for the Treatment of Acne Vulgaris

NCT03290027

Phase 3 Completed 550 enrolled Dr. Reddy's Laboratories Limited
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Enrollment of subjects with mild to moderate facial acne. Efficacy was assessed by using an Investigator's Global Assessment scale (IGA 5 point scale) and by counting the number of inflammatory and non-inflammatory lesions on the face at Baseline and Weeks 4, 8, and 12. Safety assessments included the investigator's assessment of local cutaneous tolerance of the treated skin (dryness, non-lesional erythema, peeling, stinging, burning, and itching, vital signs, and adverse events (AEs).

Timeline

Start
2017-07-31
Primary completion
2018-04-19
Completion
2018-04-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Tazarotene Small molecule 0.1 %

Indications