A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Azeliac Acid Gel and Active Treatments to a Placebo Control in the Treatment of Moderate Facial Rosacea.
Overview
- Phase
- Phase 1
- Intervention
- Azelaic Acid 15% topical gel
- Conditions
- Rosacea
- Sponsor
- Taro Pharmaceuticals USA
- Enrollment
- 1000
- Primary Endpoint
- Change in inflammatory lesion counts
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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;
Arms & Interventions
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
Intervention: Azelaic Acid 15% topical gel
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
Intervention: Finacea® (azelaic acid) Gel, 15%
Placebo
Topically to the face, twice a day A thin layer of study treatment was gently massaged into the affected areas on the face
Intervention: Placebo
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