At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 462 enrolled
Drug / intervention
Brimonidine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Brimonidine and placebo for Rosacea. Completed, enrolled 462 participants across 16 sites.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRosacea
CountriesUnited States
CollaboratorsWatson Laboratories, Inc.
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartJul 2014
First PostedNov 2014
Primary CompletionDec 2014
TodayJul 2026
First PostedNov 13, 2014
Enrollment StartJul 1, 2014
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 11.6 years ago
Interventions
Brimonidinedrug
placebodrug