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Efficacy and Safety of AGN-199201 in Patients With Persistent Erythema Associated With Rosacea
This study will evaluate the safety and efficacy of AGN-199201 once daily compared to vehicle for the treatment of persistent moderate to severe facial erythema associated with rosacea.
Details
| Lead sponsor | Allergan |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 440 |
| Start date | 2014-05 |
| Completion | 2014-12 |
Conditions
- Erythema
- Rosacea
Interventions
- AGN-199201
- Vehicle to AGN-199201
Primary outcomes
- Percentage of Patients With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) 5-point Scales — Baseline, Day 29 (Hours 3, 6, 9, and 12)
The investigator assessed the patient's overall severity of erythema in the treatment area on the 5 point CEA scale (ranging from 0=clear skin with no signs of erythema to 4=severe erythema/fiery redness). The patient assessed the overall severity of rosacea facial redness in the treatment area on the 5 point SSA scale (ranging from 0=no signs of unwanted redness to 4=severe redness). The percentage of patients with at least a 2 grade decrease (improvement) on both CEA and SSA from baseline was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on day 29. Baseline was defined as the measurement at predose on Day 1.
Countries
United States