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AGN-199201 for the Treatment of Erythema With Rosacea
This study will evaluate the safety and efficacy of 3 doses of AGN-199201 once and twice daily compared to vehicle for the treatment of moderate to severe facial erythema associated with rosacea.
Details
| Lead sponsor | Allergan |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 357 |
| Start date | 2012-12 |
| Completion | 2013-06 |
Conditions
- Rosacea
- Erythema
Interventions
- AGN-199201 Dose A
- AGN-199201 Dose B
- AGN-199201 Dose C
- AGN-199201 Vehicle
Primary outcomes
- Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) — Baseline, Day 28-hours 2 to 12
Percentage of participants with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score were assessed on Day 28 hours 2 to 12. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.
Countries
United States