NCT03287791

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 924 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Topical azelaic acid is used to treat inflammatory papules and pustules of mild to moderate rosacea. Other topical therapies and oral antibiotics are also used to treat rosacea symptoms. Finacea® (azelaic acid) Foam, 15% contains azelaic acid, a naturally occurring saturated dicarboxylic acid that has proven anti-inflammatory effects, as well as anti-keratinizing and antimicrobial actions.

Conditions

• Rosacea

Interventions

Type	Name	Description
DRUG	Generic Azelaic Acid Foam	Topical foam, generic formulation of the brand product.
DRUG	Finacea® (Azelaic Acid) Foam	Topical foam, brand product.
DRUG	Vehicle Foam	Topical foam, placebo. Has no active ingredient.
OTHER	Cleanser	A mild cleanser provided to participants, so they can wash their face prior to applying the study drug.
OTHER	Sunscreen	Sunscreen provided to participants, so they can apply it to their face when outdoors.
OTHER	Towel	A soft towel provided to participants, so they can pat their face dry after washing and prior to applying the study drug.
OTHER	Moisturizing Lotion	Moisturizing lotion provided to participants, so they can apply it to their face, as needed.

Timeline

• Start date: 2016-07-19
• Primary completion: 2017-06-22
• Completion: 2017-06-22
• First posted: 2017-09-19
• Last updated: 2019-07-31
• Results posted: 2019-07-17

Locations

26 sites across 1 country: United States

Regulatory

• FDA-regulated drug study