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Comparative Safety and Efficacy of Two Rosacea Products in the Treatment of Facial Erythema of Rosacea
To compare safety and efficacy of Perrigo's rosacea drug product compared to an FDA approved rosacea drug product in the treatment of facial erythema of rosacea.
Details
| Lead sponsor | Padagis LLC |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 552 |
| Start date | 2015-03 |
| Completion | 2015-12 |
Conditions
- Rosacea
Interventions
- Brimonidine Topical Gel, 0.33 percent (Perrigo)
- Brimonidine Topical Gel, 0.33 percent (Reference)
- Placebo gel
Primary outcomes
- Proportion of Subjects With Composite Success — Day 15 at hour 6
2-grade improvement on both the Clinician's Erythema Assessment (CEA) and the Patient Self Assessment (PSA) scales