A Long-Term Safety and Efficacy Study AGN-19920 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 long-term safety and efficacy of oxymetazoline hydrogen chloride (HCL) Cream 1.0% (AGN-199201) in patients with persistent erythema associated with rosacea.

Official Title
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A Long-term Safety and Efficacy Study of Oxymetazoline HCl Cream 1.0% in Patients With Persistent Erythema Associated With Rosacea

Conditions
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Erythema, Rosacea

Intervention / Treatment
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* Drug: Oxymetazoline HCL Cream 1.0%


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: 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxymetazoline HCL Cream 1.0%<br>Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks. | Drug: Oxymetazoline HCL Cream 1.0%<br>* Oxymetazoline HCL Cream 1.0% applied to the face once daily for 52 weeks.<br>* Other names: AGN-199201;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Treatment-Related Adverse Events | An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. A Treatment-Related Adverse Event is an Adverse Event determined by the investigator to be causally related to the study medication. | 56 Weeks | 

Secondary 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 Satisfaction Assessment (SSA) Using 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 6-hour evaluation period (hours 3 and 6) post-dose. | Baseline, Day 1 Hours 3 and 6, Week 4 Predose and Hours 3 and 6, Week 12 Predose, Week 26 Predose and Hours 3 and 6, Week 39 Predose, Week 52 Predose and Hours 3 and 6, Week 54 Predose |