A Study to Evaluate the Safety and Clinical Study of Azelaic Acid Gel 15% in Patients With Moderate Facial Rosacea

Summary

The purpose of the study is to compare the safety and efficacy profiles of a generic Azelaic Acid Gel, 15% to the reference listed Finacea® (azelaic acid) Gel, 15% in the treatment of moderate facial rosacea.

Timeline

Start

2013-07

Primary completion

2014-09

Completion

2014-09

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

registry analysis (equivalence test); Azelaic Acid, 15% Topical Gel vs Finacea® (Azelaic Acid) Gel, 15%; Mean Difference (Net) 0.98 (90% CI 0.92 to 1.05) NCT02120924 ↗

Drugs

Indications