Efficacy and Safety of AGN-199201 in Patients With Persistent Erythema Associated With Rosacea
- Registration Number
- NCT02131636
- Lead Sponsor
- Allergan
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 440
-Moderate to severe persistent facial erythema associated with rosacea.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vehicle Vehicle to AGN-199201 Vehicle to AGN-199201 applied to the face once daily for 29 days. AGN-199201 AGN-199201 AGN-199201 applied to the face once daily for 29 days.
- Primary Outcome Measures
Name Time Method 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 Baseline, Day 29 (Hours 3, 6, 9, and 12) 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.
- Secondary Outcome Measures
Name Time Method Percentage of Patients With at Least a 2-Grade Decrease From Baseline on the SSA 5-point Scale Baseline, Day 29 (Hours 3, 6, 9, and 12) 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.
Percent Change From Baseline in Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA) Baseline, Day 29 (Hours 3, 6, 9, and 12) 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).
Percentage of Patients Reporting Treatment Satisfaction on the Satisfaction Assessment for Rosacea Facial Redness (SA-RFR) Questionnaire Item 9 Day 29 (Hours 3, 6, 9, and 12) 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.
Change From Baseline on the SA-RFR Questionnaire Item #4 Baseline, Day 29 (Hours 3, 6, 9, and 12) 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).
Percentage of Patients With at Least a 1-Grade Decrease From Baseline on the SSA 5-point Scale Baseline, Day 1 (Hour 1) 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.