Efficacy and Safety of AGN-199201 in Patients With Persistent Erythema Associated With Rosacea
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 440
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe persistent facial erythema associated with rosacea.
排除标准
- •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.
研究组 & 干预措施
AGN-199201
AGN-199201 applied to the face once daily for 29 days.
干预措施: AGN-199201 (Drug)
Vehicle
Vehicle to AGN-199201 applied to the face once daily for 29 days.
干预措施: Vehicle to AGN-199201 (Drug)
结局指标
主要结局
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
时间窗: 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.
次要结局
- 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))
- Percent Change From Baseline in Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA)(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(Day 29 (Hours 3, 6, 9, and 12))
- Change From Baseline on the SA-RFR Questionnaire Item #4(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(Baseline, Day 1 (Hour 1))