To Evaluate the Therapeutic Equivalence and Safety of Azelaic Acid 15% Topical Gel

• Status: Completed
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

Summary

A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Taro Pharmaceuticals USA
• Treatments: Azelaic acid

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;