At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Double-Blind, Randomized, Parallel-Group, Vehicle-Controlled Study to Evaluate Safety and Clinical Equivalence of a Generic Azelaic Acid Foam, 15% and the Reference Listed Finacea® (Azelaic Acid) Foam,15% in Patients With Moderate Facial Rosacea
In Brief
A Phase 3 clinical trial evaluating Generic Azelaic Acid Foam, Finacea® (Azelaic Acid) Foam, and 5 other interventions for Rosacea. Completed, enrolled 924 participants across 26 sites.
Detailed 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.
Study Details
Timeline
Interventions
Topical foam, generic formulation of the brand product.
Topical foam, brand product.
Topical foam, placebo. Has no active ingredient.
A mild cleanser provided to participants, so they can wash their face prior to applying the study drug.
Sunscreen provided to participants, so they can apply it to their face when outdoors.
A soft towel provided to participants, so they can pat their face dry after washing and prior to applying the study drug.
Moisturizing lotion provided to participants, so they can apply it to their face, as needed.