Conditions: Rosacea
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 462
Healthy volunteers: no

Brief summary:
A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel-Design Study to Evaluate the Safety and Therapeutic Equivalence of Brimonidine Topical Gel, 0.33% (Watson Laboratories, Inc., USA) to Reference Product Mirvaso® (brimonidine) topical gel, 0.33% (Galderma Laboratories, L.P., USA) in Patients with Moderate to Severe Facial Erythema Associated with Rosacea

Detailed description:
Up to 462 patients 18 years of age and older, with confirmed clinical diagnosis of rosacea will be enrolled to have 413 in the modified intent-to-treat (mITT) population and 371 in the per-protocol (PP) population. Patients should have fewer than 3 facial inflammatory lesions, and moderate to severe erythema according to both Clinician's Erythema Assessment (CEA) and Patient's Self-Assessment (PSA).

Arms:
arm 1: Brimonidine Topical Gel, 0.33%, 30 gram fill (Watson Laboratories, Inc., USA) arm 2: Mirvaso® (brimonidine) topical gel, 0.33% (Galderma Laboratories, L.P., USA) arm 3: Topical gel base only (Watson Laboratories Inc., USA)

Interventions: intervention 1: Brimonidine intervention 2: placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: