NCT03292640

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 547 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 9 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Enrollment of subjects with mild to moderate facial acne vulgaris. Acne lesions of any severity on the chest and/or back (including shoulders) were enrolled provided they had mild to moderate acne on the face. During the 12-week treatment period subjects used the study product twice daily with approximately 12 hours between applications. Subjects were instructed to treat the entire face (and chest/back including shoulders, if applicable). 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. The primary safety endpoint was treatment-emergent adverse events (TEAEs). Other safety variables included local cutaneous tolerance evaluation (dryness, non-lesional erythema, peeling, stinging, burning, and itching) and vital signs (blood pressure and pulse rate). Urine pregnancy tests were performed at Baseline and at every visit through Week 12 for all female subjects. A physical examination was performed at the Baseline Visit.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	DFD-03 (0.1% tazarotene) Lotion	DFD-03 Lotion (0.1% tazarotene) - twice daily application
DRUG	DFD-03 (0% tazarotene) Lotion (Placebo)	DFD-03 Vehicle Lotion (0% tazarotene) - twice daily application

Timeline

• Start date: 2017-07-06
• Primary completion: 2018-05-14
• Completion: 2018-05-14
• First posted: 2017-09-25
• Last updated: 2021-03-01
• Results posted: 2020-06-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study