To Evaluate the Therapeutic Equivalence and Safety of Azelaic Acid 15% Topical Gel
Phase 1
Completed
- Conditions
- Rosacea
- Interventions
- Registration Number
- NCT03094403
- Lead Sponsor
- Taro Pharmaceuticals USA
- Brief Summary
A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study
- Detailed Description
A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, comparing AZELAIC ACID TOPICAL GEL 15% TO FINACEA® and both active treatments to a Placebo Control in the treatment of Moderate of Facial Rosacea.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1000
Inclusion Criteria
- Healthy male or non-pregnant female ≥ 18 years-of-age with a clinical diagnosis of moderate facial rosacea;
- Subjects had to have a definite clinical diagnosis of facial rosacea severity Grade 3 as per the IGE
Exclusion Criteria
- Female subjects who were pregnant, nursing, or planning to become pregnant during study participation;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Topically to the face, twice a day A thin layer of study treatment was gently massaged into the affected areas on the face Azelaic Acid 15% topical gel Azelaic Acid 15% topical gel Topical, twice daily, for 84 days A thin layer of study treatment was gently massaged into the affected areas on the face Finacea® (azelaic acid) Gel, 15% Finacea® (azelaic acid) Gel, 15% Topical, twice daily, for 84 days A thin layer of study treatment was gently massaged into the affected areas on the face
- Primary Outcome Measures
Name Time Method Change in inflammatory lesion counts 12 weeks Percent change from baseline to Week 12 in the inflammatory (papules and pustules) lesion counts
- Secondary Outcome Measures
Name Time Method