A Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-group Study to Evaluate the Efficacy and Safety of ADPS in the Treatment of Acne Vulgaris
Overview
- Phase
- Phase 2
- Intervention
- ADPS topical product
- Conditions
- Acne Vulgaris
- Sponsor
- Taro Pharmaceuticals USA
- Enrollment
- 294
- Primary Endpoint
- Percent Change From Baseline to Week 12 in the Inflammatory (Papules and Pustules) Lesion Counts on the Face
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
Safety and efficacy study in patients with acne vulgaris
Detailed Description
randomized, double-blind, placebo controlled, parallel-group, multiple-center study to evaluate the efficacy and safety of ADPS in the treatment of acne vulgaris.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy male or non pregnant female aged ≥ 9 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
ADPS topical product
A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks
Intervention: ADPS topical product
Placebo Control
A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks
Intervention: Placebo Control
Outcomes
Primary Outcomes
Percent Change From Baseline to Week 12 in the Inflammatory (Papules and Pustules) Lesion Counts on the Face
Time Frame: Baseline to week 12 (study day 84)
Percent Change From Baseline to Week 12 in the Non-inflammatory (Open and Closed Comedones) Lesion Counts on the Face
Time Frame: Baseline to week 12 (study day 84)
The Percentage of Subjects With a Clinical Response (IGA) of "Success" at Week 12 on the Face.
Time Frame: Baseline to Week 12 (study day 84)
Success was defined as an IGA score that was at least two grades less than the baseline assessment.