A Multicenter, Double-blind, Randomized, Parallel-group, Vehicle-Controlled Study to Evaluate the Safety and Clinical Equivalence of a Generic Azelaic Acid Gel, 15% and the Reference Listed Finacea® (Azelaic Acid) Gel, 15% in Patients With Moderate Facial Rosacea.

NCT02120924 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Actavis Inc.
Phase	Phase 3
Status	COMPLETED
Enrolment	1009
Start date	2013-07
Completion	2014-09

Conditions

• Rosacea

Interventions

• Azelaic acid
• Vehicle
• Finacea

Primary outcomes

• Percent Change From Baseline to Week 12 in the Inflammatory (Papules and Pustules) Lesion Counts. — Baseline to Week 12
  Percent change from baseline to Week 12 in the inflammatory (papules and pustules) lesion counts in PP population.

Countries

United States