To Evaluate the Therapeutic Equivalence and Safety in Treatment of Moderate Facial Rosacea

• Status: Completed
• Trial end date: 2018-09-28
• Target enrollment: 0
• Participant gender: All

Summary

To demonstrate the superiority of the efficacy of the test and reference products over that of the placebo control in the treatment of moderate facial rosacea.

• 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 aged ≥ 18 with a clinical diagnosis of facial rosacea.

• Subjects must have provided IRB approved written informed consent.

Exclusion Criteria:

• Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.

• Subjects who have used estrogens or oral contraceptives for less than 3 months prior to baseline; use of such therapy must remain constant throughout the study.