AGN-199201 for the Treatment of Erythema With Rosacea
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 357
- 主要终点
- Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA)
研究概览
简要总结
This study will evaluate the safety and efficacy of 3 doses of AGN-199201 once and twice daily compared to vehicle for the treatment of 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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Redness of the skin caused by rosacea
排除标准
- •≥3 inflammatory lesions
- •Laser light-source or other energy based therapy in the last 6 months
- •Any prescription or over the counter product for the treatment of acne or rosacea in the last 14 days
研究组 & 干预措施
AGN-199201 Dose A Once Daily
AGN-199201 Dose A applied once daily to the face for 28 days.
干预措施: AGN-199201 Dose A (Drug)
AGN-199201 Dose B Once Daily
AGN-199201 Dose B applied once daily to the face for 28 days.
干预措施: AGN-199201 Dose B (Drug)
AGN-199201 Dose C Once Daily
AGN-199201 Dose C applied once daily to the face for 28 days.
干预措施: AGN-199201 Dose C (Drug)
AGN-199201 Vehicle Once Daily
AGN-199201 Vehicle applied once daily to the face for 28 days.
干预措施: AGN-199201 Vehicle (Drug)
AGN-199201 Dose A Twice Daily
AGN-199201 Dose A applied twice daily to the face for 28 days.
干预措施: AGN-199201 Dose A (Drug)
AGN-199201 Dose B Twice Daily
AGN-199201 Dose B applied twice daily to the face for 28 days.
干预措施: AGN-199201 Dose B (Drug)
AGN-199201 Dose C Twice Daily
AGN-199201 Dose C applied twice daily to the face for 28 days.
干预措施: AGN-199201 Dose C (Drug)
AGN-199201 Vehicle Twice Daily
AGN-199201 Vehicle applied twice daily to the face for 28 days.
干预措施: AGN-199201 Vehicle (Drug)
结局指标
主要结局
Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA)
时间窗: Baseline, Day 28-hours 2 to 12
Percentage of participants with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score were assessed on Day 28 hours 2 to 12. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.
次要结局
- Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both CEA and SSA at 0.5 Hour Post-Dose on Day 28(Baseline, Day 28-hour 0.5)
- Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both CEA and SSA at 1 Hour Post-Dose on Day 28(Baseline, Day 28-hour 1)