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Brimonidine Topical Gel for Facial Erythema of Rosacea
NCT02385240Phase 3
Key facts
- Status
- Completed
- Start
- Mar 2015
- Primary completion
- Dec 2015
- Sponsor
- Padagis
- Modality
- Small Molecules
- Conditions
- rosacea
01
Overview
Phase 3, randomised, double-blind trial of brimonidine transdermal lotion in rosacea (3 arms), sponsored by Padagis. Primary endpoint: Proportion of Subjects With Composite Success at Day 15. Started Mar 2015; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Test Product
Brimonidine Topical Gel, 0.33 percent (Perrigo)
Reference Product
Brimonidine Topical Gel, 0.33 percent (Mirvaso)
Placebo
Placebo Gel
03
Who it enrols
Adult patients with a diagnosis of rosacea and moderate to severe facial erythema (CEA >= 3 and PSA >= 3). Patients with more than 3 inflammatory lesions, Raynaud's syndrome, or severe cardiovascular disease are excluded.
04
Endpoints
Primary
Proportion of Subjects With Composite Success
Secondary
Proportion of Subjects With Composite Success at Hour 3
Proportion of Subjects With Composite Success at Hour 9
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