| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01735201 | AGN-199201 for the Treatment of Erythema With Rosacea | PHASE2 | COMPLETED | 357 | — | — | Dec 1, 2012 | Jun 1, 2013 | Nov 18, 2019 | 1 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| AGN-199201 Dose A Once Daily | EXPERIMENTAL | AGN-199201 Dose A applied once daily to the face for 28 days. |
| AGN-199201 Dose B Once Daily | EXPERIMENTAL | AGN-199201 Dose B applied once daily to the face for 28 days. |
| AGN-199201 Dose C Once Daily | EXPERIMENTAL | AGN-199201 Dose C applied once daily to the face for 28 days. |
| AGN-199201 Vehicle Once Daily | PLACEBO_COMPARATOR | AGN-199201 Vehicle applied once daily to the face for 28 days. |
| AGN-199201 Dose A Twice Daily | EXPERIMENTAL | AGN-199201 Dose A applied twice daily to the face for 28 days. |
| AGN-199201 Dose B Twice Daily | EXPERIMENTAL | AGN-199201 Dose B applied twice daily to the face for 28 days. |
| AGN-199201 Dose C Twice Daily | EXPERIMENTAL | AGN-199201 Dose C applied twice daily to the face for 28 days. |
| AGN-199201 Vehicle Twice Daily | PLACEBO_COMPARATOR | AGN-199201 Vehicle applied twice daily to the face for 28 days. |
| Name | Type | Description |
|---|---|---|
| AGN-199201 Dose A | DRUG | AGN-199201 Dose A applied once or twice daily to the face for 28 days. |
| AGN-199201 Dose B | DRUG | AGN-199201 Dose B applied once or twice daily to the face for 28 days. |
| AGN-199201 Dose C | DRUG | AGN-199201 Dose C applied once or twice daily to the face for 28 days. |
| AGN-199201 Vehicle | DRUG | AGN-199201 Vehicle applied once or twice daily to the face for 28 days. |
Inclusion Criteria: * Redness of the skin caused by rosacea Exclusion Criteria: * ≥3 inflammatory lesions * Laser light-source or other energy based therapy in the last 6 months * Any prescription or over the counter product for the treatment of acne or rosacea in the last 14 days