Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris
Phase 1
Completed
- Conditions
- Acne Vulgaris
- Interventions
- Registration Number
- NCT04321070
- Lead Sponsor
- Taro Pharmaceuticals USA
- Brief Summary
Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris
- Detailed Description
Randomized, Double-Blind, Multiple Center Placebo Controlled Study Comparing Taro Product to RLD and Both Treatments to a Placebo Control in the Treatment of Acne Vulgaris
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 550
Inclusion Criteria
- Healthy male or non pregnant female aged ≥ 12 and ≤ 40years with a clinical diagnosis of acne vulgaris.
- Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB approved written informed consent.
- Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA).
Exclusion Criteria
- Female Subjects who are pregnant, nursing or planning to become pregnant during study participation
- Subjects with a history of hypersensitivity or allergy to adapalene, retinoids and/or any of the study medication ingredients, have a known hypersensitivity to adapalene and benzoyl peroxide and its excitements.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Clindamycin Phosphate Clindamycin Phosphate Topical, once daily, for 84 days. Clindamycin Phosphate RLD Clindamycin Phosphate RLD Topical, once daily, for 84 days Vehicle of the test product Placebos Topical, once daily, for 84 days
- Primary Outcome Measures
Name Time Method Demonstration of Bioequivalence Week 12 Demonstration of Bioequivalence in percent change in inflammatory and non-inflammatory lesion counts
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Catawba Research LLC
🇺🇸Charlotte, North Carolina, United States