Safety and Tolerability of AGN-199201 in Patients With Erythema Associated With Rosacea

Study Overview
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Brief Summary
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This study will evaluate the safety and tolerability of AGN-199201 for the treatment of erythema associated with rosacea.

Conditions
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Rosacea, Erythema

Intervention / Treatment
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* Drug: AGN-199201 Formulation A
* Drug: AGN-199201 Formulation B
* Drug: AGN-199201 Formulation C
* Drug: AGN-199201 Vehicle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AGN-199201 Formulation A and B<br>AGN-199201 Formulation A applied to one side of the face and Formulation B applied to the other side of the face twice daily. | Drug: AGN-199201 Formulation A<br>* AGN-199201 Formulation A applied to the face as per protocol twice daily.<br>Drug: AGN-199201 Formulation B<br>* AGN-199201 Formulation B applied to the face as per protocol twice daily.<br>|
| Experimental: AGN-199201 Formulation B and C<br>AGN-199201 Formulation B applied to one side of the face and Formulation C applied to the other side of the face twice daily. | Drug: AGN-199201 Formulation B<br>* AGN-199201 Formulation B applied to the face as per protocol twice daily.<br>Drug: AGN-199201 Formulation C<br>* AGN-199201 Formulation C applied to the face as per protocol twice daily.<br>|
| Experimental: AGN-199201 Formulation C and A<br>AGN-199201 Formulation C applied to one side of the face and Formulation A applied to the other side of the face twice daily. | Drug: AGN-199201 Formulation A<br>* AGN-199201 Formulation A applied to the face as per protocol twice daily.<br>Drug: AGN-199201 Formulation C<br>* AGN-199201 Formulation C applied to the face as per protocol twice daily.<br>|
| Other: AGN-199201 Formulation A and Vehicle<br>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. | Drug: AGN-199201 Formulation A<br>* AGN-199201 Formulation A applied to the face as per protocol twice daily.<br>Drug: AGN-199201 Vehicle<br>* AGN-199201 vehicle (placebo) applied to the face as per protocol twice daily.<br>|
| Other: AGN-199201 Formulation B and Vehicle<br>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. | Drug: AGN-199201 Formulation B<br>* AGN-199201 Formulation B applied to the face as per protocol twice daily.<br>Drug: AGN-199201 Vehicle<br>* AGN-199201 vehicle (placebo) applied to the face as per protocol twice daily.<br>|
| Other: AGN-199201 Formulation C and Vehicle<br>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. | Drug: AGN-199201 Formulation C<br>* AGN-199201 Formulation C applied to the face as per protocol twice daily.<br>Drug: AGN-199201 Vehicle<br>* AGN-199201 vehicle (placebo) applied to the face as per protocol twice daily.<br>|
| Experimental: AGN-199201 Formulation A<br>AGN-199201 Formulation A applied to both sides of the face twice daily. | Drug: AGN-199201 Formulation A<br>* AGN-199201 Formulation A applied to the face as per protocol twice daily.<br>|
| Experimental: AGN-199201 Formulation B<br>AGN-199201 Formulation B applied to both sides of the face twice daily. | Drug: AGN-199201 Formulation B<br>* AGN-199201 Formulation B applied to the face as per protocol twice daily.<br>|
| Experimental: AGN-199201 Formulation C<br>AGN-199201 Formulation C applied to both sides of the face twice daily. | Drug: AGN-199201 Formulation C<br>* AGN-199201 Formulation C applied to the face as per protocol twice daily.<br>|
| Placebo Comparator: AGN-199201 Vehicle<br>AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily. | Drug: AGN-199201 Vehicle<br>* AGN-199201 vehicle (placebo) applied to the face as per protocol twice daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Responders With at Least a 2-Grade Decrease From Baseline in Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 1 | 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. | Baseline, Day 1-hour 6 | 
| Percentage of Responders With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 5 | 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. | Baseline, Day 5-hour 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Responders With at Least a 2-Grade Decrease From Baseline on CEA | The percentage of responders was determined by facial sides with at least a 2-grade decrease from Baseline (Improvement) in the CEA score at Day 1 and 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. | Baseline, Day 1-hour 6, Day 5-hour 6 | 
| Percentage of Responders With at Least a 2-Grade Decrease From Baseline on SSA | The percentage of responders was determined by facial sides with at least a 2-grade decrease from Baseline (Improvement) in the SSA score at Day 1 and Day 5. 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. | Baseline, Day1-hour 6, Day 5-hour 6 |