Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AGN-199201 Formulation A · 1 trial · 2 indications
The percentage of responders was determined by facial sides 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 at Day 1. 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.
The percentage of responders was determined by facial sides 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 at Day 5. 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 Formulation A and B | EXPERIMENTAL | AGN-199201 Formulation A applied to one side of the face and Formulation B applied to the other side of the face twice daily. |
| AGN-199201 Formulation B and C | EXPERIMENTAL | AGN-199201 Formulation B applied to one side of the face and Formulation C applied to the other side of the face twice daily. |
| AGN-199201 Formulation C and A | EXPERIMENTAL | AGN-199201 Formulation C applied to one side of the face and Formulation A applied to the other side of the face twice daily. |
| AGN-199201 Formulation A and Vehicle | OTHER | AGN-199201 Formulation A applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily. |
| AGN-199201 Formulation B and Vehicle | OTHER | AGN-199201 Formulation B applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily. |
| AGN-199201 Formulation C and Vehicle | OTHER | AGN-199201 Formulation C applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily. |
| AGN-199201 Formulation A | EXPERIMENTAL | AGN-199201 Formulation A applied to both sides of the face twice daily. |
| AGN-199201 Formulation B | EXPERIMENTAL | AGN-199201 Formulation B applied to both sides of the face twice daily. |
| AGN-199201 Formulation C | EXPERIMENTAL | AGN-199201 Formulation C applied to both sides of the face twice daily. |
| AGN-199201 Vehicle | PLACEBO_COMPARATOR | AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily. |
| Name | Type | Description |
|---|---|---|
| AGN-199201 Formulation A | DRUG | AGN-199201 Formulation A applied to the face as per protocol twice daily. |
| AGN-199201 Formulation B | DRUG | AGN-199201 Formulation B applied to the face as per protocol twice daily. |
| AGN-199201 Formulation C | DRUG | AGN-199201 Formulation C applied to the face as per protocol twice daily. |
| AGN-199201 Vehicle | DRUG | AGN-199201 vehicle (placebo) applied to the face as per protocol twice daily. |
Inclusion Criteria: * facial erythema associated with rosacea on both sides of the face Exclusion Criteria: * Laser light-source or other energy based therapy in the last 6 months * Excessive hair around the treatment area
AGN-199201 Formulation A is an investigational small molecule being developed for the treatment of rosacea, specifically for erythema (redness) associated with the condition. It is in Phase 1 clinical development and is not yet approved by regulatory authorities.
AGN-199201 Formulation A is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting clinical research to evaluate the safety and tolerability of this investigational drug.
AGN-199201 Formulation A is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being studied for safety and tolerability in patients with erythema associated with rosacea.
AGN-199201 Formulation A has one completed Phase 1 clinical trial registered as NCT01579084, titled "Safety and Tolerability of AGN-199201 in Patients With Erythema Associated With Rosacea." This randomized, double-blind, placebo-controlled study enrolled 64 participants in the United States.
AGN-199201 Formulation A is a specific formulation of the investigational drug AGN-199201. The clinical trial NCT01579084 evaluates AGN-199201 in patients with erythema associated with rosacea, and the formulation designation indicates a particular version being tested.