NCT02289352

Randomized, Double-blind, Multiple-site, Placebo-controlled, Parallel-design Study in Patients With Moderate to Severe Facial Erythema Associated With Rosacea

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 462 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Rosacea

Interventions

Type	Name	Description
DRUG	Brimonidine
DRUG	placebo

Timeline

• Start date: 2014-07-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2014-11-13
• Last updated: 2020-01-14
• Results posted: 2020-01-14

Locations

16 sites across 1 country: United States