AGN-199201 for the Treatment of Erythema With Rosacea

Study Overview
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Brief Summary
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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.

Conditions
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Rosacea, Erythema

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


Participation Criteria
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Eligibility Criteria
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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

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AGN-199201 Dose A Once Daily<br>AGN-199201 Dose A applied once daily to the face for 28 days. | Drug: AGN-199201 Dose A<br>* AGN-199201 Dose A applied once or twice daily to the face for 28 days.<br>|
| Experimental: AGN-199201 Dose B Once Daily<br>AGN-199201 Dose B applied once daily to the face for 28 days. | Drug: AGN-199201 Dose B<br>* AGN-199201 Dose B applied once or twice daily to the face for 28 days.<br>|
| Experimental: AGN-199201 Dose C Once Daily<br>AGN-199201 Dose C applied once daily to the face for 28 days. | Drug: AGN-199201 Dose C<br>* AGN-199201 Dose C applied once or twice daily to the face for 28 days.<br>|
| Placebo Comparator: AGN-199201 Vehicle Once Daily<br>AGN-199201 Vehicle applied once daily to the face for 28 days. | Drug: AGN-199201 Vehicle<br>* AGN-199201 Vehicle applied once or twice daily to the face for 28 days.<br>|
| Experimental: AGN-199201 Dose A Twice Daily<br>AGN-199201 Dose A applied twice daily to the face for 28 days. | Drug: AGN-199201 Dose A<br>* AGN-199201 Dose A applied once or twice daily to the face for 28 days.<br>|
| Experimental: AGN-199201 Dose B Twice Daily<br>AGN-199201 Dose B applied twice daily to the face for 28 days. | Drug: AGN-199201 Dose B<br>* AGN-199201 Dose B applied once or twice daily to the face for 28 days.<br>|
| Experimental: AGN-199201 Dose C Twice Daily<br>AGN-199201 Dose C applied twice daily to the face for 28 days. | Drug: AGN-199201 Dose C<br>* AGN-199201 Dose C applied once or twice daily to the face for 28 days.<br>|
| Placebo Comparator: AGN-199201 Vehicle Twice Daily<br>AGN-199201 Vehicle applied twice daily to the face for 28 days. | Drug: AGN-199201 Vehicle<br>* AGN-199201 Vehicle applied once or twice daily to the face for 28 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) | 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. | Baseline, Day 28-hours 2 to 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both CEA and SSA at 0.5 Hour Post-Dose on Day 28 | 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 at 0.5 hour post-dose on Day 28. 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 28-hour 0.5 | 
| Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both CEA and SSA at 1 Hour Post-Dose on Day 28 | 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 at 1 hour post-dose on Day 28. 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 28-hour 1 |