Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02131636 | Efficacy and Safety of AGN-199201 in Patients With Persistent Erythema Associated With Rosacea | PHASE3 | COMPLETED | 440 | — | — | May 1, 2014 | Dec 1, 2014 | Nov 18, 2019 | 1 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| AGN-199201 | EXPERIMENTAL | AGN-199201 applied to the face once daily for 29 days. |
| Vehicle | PLACEBO_COMPARATOR | Vehicle to AGN-199201 applied to the face once daily for 29 days. |
| Name | Type | Description |
|---|---|---|
| AGN-199201 | DRUG | AGN-199201 applied to the face once daily for 29 days. |
| Vehicle to AGN-199201 | DRUG | Vehicle to AGN-199201 applied to the face once daily for 29 days. |
Inclusion Criteria: -Moderate to severe persistent facial erythema associated with rosacea. Exclusion Criteria: * Greater than 3 inflammatory lesions on the face * Current treatment with monoamine oxidase (MAO) inhibitors * Raynaud's syndrome, narrow angle glaucoma, orthostatic hypotension, scler...