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

Study Overview
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Brief Summary
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This study will evaluate the safety and efficacy of AGN-199201 once daily compared to vehicle for the treatment of persistent moderate to severe facial erythema associated with rosacea.

Conditions
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Erythema, Rosacea

Intervention / Treatment
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* Drug: AGN-199201
* Drug: Vehicle to AGN-199201


Participation Criteria
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Eligibility Criteria
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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, scleroderma or Sjogren's syndrome.

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<br>AGN-199201 applied to the face once daily for 29 days. | Drug: AGN-199201<br>* AGN-199201 applied to the face once daily for 29 days.<br>|
| Placebo Comparator: Vehicle<br>Vehicle to AGN-199201 applied to the face once daily for 29 days. | Drug: Vehicle to AGN-199201<br>* Vehicle to AGN-199201 applied to the face once daily for 29 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) 5-point Scales | 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. | Baseline, Day 29 (Hours 3, 6, 9, and 12) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With at Least a 2-Grade Decrease From Baseline on the SSA 5-point Scale | 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) 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. | Baseline, Day 29 (Hours 3, 6, 9, and 12) | 
| Percent Change From Baseline in Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA) | Rosacea facial redness in the treatment area was measured by DIA. The percent change 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. A negative number change from baseline indicates a decrease in facial redness (improvement), and a positive number change from baseline indicates an increase in facial redness (worsening). | Baseline, Day 29 (Hours 3, 6, 9, and 12) | 
| Percentage of Patients Reporting Treatment Satisfaction on the Satisfaction Assessment for Rosacea Facial Redness (SA-RFR) Questionnaire Item 9 | The SA-RFR questionnaire item 9 is completed by patients assessing treatment satisfaction on facial redness. Patients reporting treatment satisfaction as very satisfied or satisfied are noted. The percentage of patients was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on Day 29. | Day 29 (Hours 3, 6, 9, and 12) | 
| Change From Baseline on the SA-RFR Questionnaire Item #4 | The SA-RFR questionnaire item 4 is completed by patients assessing how much their face burned due to facial redness on a 5 point scale (range 0=does not burn at all and 4=burns a lot). Patients were evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on Day 29. A lower score change from baseline (negative number) indicates a decrease in facial redness (improvement), and a higher score change from baseline (positive number) indicates an increase in facial burning (worsening). | Baseline, Day 29 (Hours 3, 6, 9, and 12) | 
| Percentage of Patients With at Least a 1-Grade Decrease From Baseline on the SSA 5-point Scale | 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 1 grade decrease (improvement) on the SSA from baseline at Day 1 hour 1. Baseline was defined as the measurement at predose on Day 1. | Baseline, Day 1 (Hour 1) |