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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- 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
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 9 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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 (Drug)
Placebo Control
A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks
Intervention: Placebo Control (Drug)
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.
Secondary Outcomes
No secondary outcomes reported