A Single-center, Double-blind, Randomized, Parallel-group Study, Comparing DPSG to a Placebo Control in the Treatment of Acne Vulgaris
Overview
- Phase
- Phase 1
- Intervention
- DPSG 7.5%
- Conditions
- Acne Vulgaris
- Sponsor
- Taro Pharmaceuticals USA
- Enrollment
- 1125
- Primary Endpoint
- Change in inflammatory lesion counts
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
To evaluate the therapeutic effect of DPSG and Placebo gel in the treatment of acne vulgaris.
Detailed Description
A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group study comparing DPSG to ACZONE Gel and active treatment to a Placebo control in the treatment of Acne Vulgaris.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy male or non pregnant female aged ≥ 12 years with a clinical diagnosis of acne vulgaris.
Exclusion Criteria
- •Female Subjects who are pregnant, nursing or planning to become pregnant during study participation
Arms & Interventions
DPSG 7.5%
DPSG 7.5% (Taro Pharmaceuticals USA) Topical, twice daily on the face for 84 days.
Intervention: DPSG 7.5%
Vehicle Gel
Placebo product (Taro Pharmaceuticals Inc.) Topical, twice daily on the face for 84 days.
Intervention: Placebo
Aczone
dapsone 7.5 Topical, twice daily on the face for 84 days.
Intervention: Aczone
Outcomes
Primary Outcomes
Change in inflammatory lesion counts
Time Frame: 12 weeks
Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts
Change in non-inflammatory lesion counts
Time Frame: 12 weeks
Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts
Secondary Outcomes
- Clinical response of success(12 weeks)