Safety and Tolerability of AGN-199201 in Patients With Erythema Associated With Rosacea
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 64
- 主要终点
- Percentage of Responders With at Least a 2-Grade Decrease From Baseline in Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 1
研究概览
简要总结
This study will evaluate the safety and tolerability of AGN-199201 for the treatment of 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
- •facial erythema associated with rosacea on both sides of the face
排除标准
- •Laser light-source or other energy based therapy in the last 6 months
- •Excessive hair around the treatment area
研究组 & 干预措施
AGN-199201 Formulation A and B
AGN-199201 Formulation A applied to one side of the face and Formulation B applied to the other side of the face twice daily.
干预措施: AGN-199201 Formulation A (Drug)
AGN-199201 Formulation A and B
AGN-199201 Formulation A applied to one side of the face and Formulation B applied to the other side of the face twice daily.
干预措施: AGN-199201 Formulation B (Drug)
AGN-199201 Formulation B and C
AGN-199201 Formulation B applied to one side of the face and Formulation C applied to the other side of the face twice daily.
干预措施: AGN-199201 Formulation B (Drug)
AGN-199201 Formulation B and C
AGN-199201 Formulation B applied to one side of the face and Formulation C applied to the other side of the face twice daily.
干预措施: AGN-199201 Formulation C (Drug)
AGN-199201 Formulation C and A
AGN-199201 Formulation C applied to one side of the face and Formulation A applied to the other side of the face twice daily.
干预措施: AGN-199201 Formulation A (Drug)
AGN-199201 Formulation C and A
AGN-199201 Formulation C applied to one side of the face and Formulation A applied to the other side of the face twice daily.
干预措施: AGN-199201 Formulation C (Drug)
AGN-199201 Formulation A and Vehicle
AGN-199201 Formulation A applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily.
干预措施: AGN-199201 Formulation A (Drug)
AGN-199201 Formulation A and Vehicle
AGN-199201 Formulation A applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily.
干预措施: AGN-199201 Vehicle (Drug)
AGN-199201 Formulation B and Vehicle
AGN-199201 Formulation B applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily.
干预措施: AGN-199201 Formulation B (Drug)
AGN-199201 Formulation B and Vehicle
AGN-199201 Formulation B applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily.
干预措施: AGN-199201 Vehicle (Drug)
AGN-199201 Formulation C and Vehicle
AGN-199201 Formulation C applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily.
干预措施: AGN-199201 Formulation C (Drug)
AGN-199201 Formulation C and Vehicle
AGN-199201 Formulation C applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily.
干预措施: AGN-199201 Vehicle (Drug)
AGN-199201 Formulation A
AGN-199201 Formulation A applied to both sides of the face twice daily.
干预措施: AGN-199201 Formulation A (Drug)
AGN-199201 Formulation B
AGN-199201 Formulation B applied to both sides of the face twice daily.
干预措施: AGN-199201 Formulation B (Drug)
AGN-199201 Formulation C
AGN-199201 Formulation C applied to both sides of the face twice daily.
干预措施: AGN-199201 Formulation C (Drug)
AGN-199201 Vehicle
AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily.
干预措施: AGN-199201 Vehicle (Drug)
结局指标
主要结局
Percentage of Responders With at Least a 2-Grade Decrease From Baseline in Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 1
时间窗: Baseline, Day 1-hour 6
The percentage of responders was determined by facial sides 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 at Day 1. 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.
Percentage of Responders With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 5
时间窗: Baseline, Day 5-hour 6
The percentage of responders was determined by facial sides 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 at Day 5. 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 Responders With at Least a 2-Grade Decrease From Baseline on CEA(Baseline, Day 1-hour 6, Day 5-hour 6)
- Percentage of Responders With at Least a 2-Grade Decrease From Baseline on SSA(Baseline, Day1-hour 6, Day 5-hour 6)