At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Study of the Safety and Efficacy of DFD-03 Lotion in the Treatment of Acne Vulgaris for 12 Weeks
In Brief
A Phase 3 clinical trial evaluating DFD-03 (0.1% tazarotene) Lotion and DFD-03 (0% tazarotene) Lotion (Placebo) for Acne Vulgaris. Completed, enrolled 547 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
DFD-03 Lotion (0.1% tazarotene) - twice daily application
DFD-03 Vehicle Lotion (0% tazarotene) - twice daily application