Safety and Efficacy of Oxymetazoline HCl Cream 1.0% 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 oxymetazoline hydrochloride (HCl) cream 1.0% (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: Oxymetazoline HCL Cream 1.0%
* Drug: Vehicle to Oxymetazoline HCL Cream


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: Oxymetazoline HCL Cream 1.0%<br>Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days. | Drug: Oxymetazoline HCL Cream 1.0%<br>* Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 29 days.<br>|
| Placebo Comparator: Vehicle<br>Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days. | Drug: Vehicle to Oxymetazoline HCL Cream<br>* Vehicle to Oxymetazoline HCL Cream (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 Participants With at Least a 2-Grade Improvement (Decrease) From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment for Rosacea Facial Redness (SSA) 5-point Scales | The investigator assessed the participant's overall severity of erythema in the treatment area by using the 5-point CEA scale with photonumeric guide where: 0=clear skin with no signs of erythema (best) to 4=severe erythema; fiery redness (worst). A decrease in the score indicates improvement. The participant assessed their overall severity of rosacea facial redness in the treatment area by using the 5-point SSA scale with photoguide where: 0=no signs of unwanted redness (best) to 4=severe redness (worst). A decrease in the score indicates improvement. The percentage of participants 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) post-dose on Day 29. Baseline was defined as the measurement at pre-dose on Day 1. | Baseline, Day 29 (Hours 3, 6, 9 and 12) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With at Least a 2-Grade Improvement (Decrease) From Baseline on SSA at Hours 3, 6, 9 and 12 on Day 29 | The participant assessed their overall severity of rosacea facial redness in the treatment area by using the 5-point SSA scale with photoguide where: 0=no signs of unwanted redness (best) to 4=severe redness (worst). A decrease in the score indicates improvement. The percentage of participants with at least a 2-grade decrease (improvement) on SSA from Baseline was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) post-dose on Day 29. | Baseline, Day 29 (Hours 3, 6, 9 and 12) | 
| Percent Change From Baseline on Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA) at Hours 3, 6, 9 and 12 on Day 29 | DIA of photographs was used to assess rosacea facial redness and was defined as percentage of facial area occupied by redness. A higher value in the percentage of facial area occupied by facial redness indicated more redness. A negative/ lower number percent change from Baseline indicates improvement. | Baseline, Day 29 (Hours 3, 6, 9 and 12) | 
| Percentage of Participants Satisfied or Very Satisfied on Item #9 of Satisfaction Assessment for Rosacea Facial Redness (SAT-RFR) at Hours 3, 6, 9 and 12 on Day 29 | Participants assessed their treatment satisfaction by answering Item #9 of the SAT-RFR: Right now, how satisfied are you with the effect your study medication had on your facial redness? using a 5-point scale where 0= very dissatisfied, 1=dissatisfied, 2=neither satisfied or dissatisfied, 3=satisfied, or 4=very satisfied. The percentage of participants who answered Satisfied or Very Satisfied is reported. | Day 29 (Hours 3, 6, 9 and 12) | 
| Change From Baseline on the Symptom Assessment for Rosacea Facial Redness (SA-RFR) Item # 4 at Hours 3, 6, 9 and 12 on Day 29 | Participants assessed the burning sensation associated with rosacea facial redness by answering Item #4 of the SA-RFR: Right now, how much does your face burn because of your facial redness? using a 5-point scale where 0=less severe to 4=severe. A negative change from Baseline indicates improvement. | Baseline, Day 29 (Hours 3, 6, 9 and 12) | 
| Percentage of Participants With at Least a 1-Grade Improvement (Decrease) From Baseline on SSA at Hour 1 on Day 1 | The participant assessed their overall severity of rosacea facial redness in the treatment area by using the 5-point SSA scale with photoguide where: 0=no signs of unwanted redness (best) to 4=severe redness (worst). A decrease in the score indicates improvement. | Baseline, Day 1 (Hour 1) |