A Study to Evaluate Safety and Equivalence of Generic Azelaic Acid Foam and Finacea® Foam in Participants With Rosacea

Summary

The objectives of this study were to compare the safety and efficacy profiles of a generic Azelaic Acid Foam, 15% to the reference listed Finacea® (azelaic acid) Foam, 15% and to demonstrate therapeutic equivalence and safety of the two active foams in the treatment of moderate facial rosacea, and to demonstrate superiority of the Reference and Test products over the Vehicle.

Timeline

Start

2016-07-19

Primary completion

2017-06-22

Completion

2017-06-22

Outcome

Met primary endpoint

registry analysis (superiority test); Generic Azelaic Acid Foam vs Vehicle Foam; p <.0001; Mean Difference (Final Values) -11.27 (95% CI -16.80 to -5.73); ANOVA NCT03287791 ↗

Drugs

Indications