A Multicenter, Randomized, Double-blind, Vehicle-controlled, Parallel-group Comparison Trial to Assess the Efficacy and Safety of 0.3% and 1% OPA-15406 Ointments in Patients With Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- Responder Rate of Investigator's Global Assessment(IGA) of Disease Severity at Week4
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of OPA-15406 ointment in patients with atopic dermatitis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of atopic dermatitis based on the criteria of Hanifin and Rajka
排除标准
- •Subjects who have an atopic dermatitis or contact dermatitis flare-up defined as a sudden intensification of atopic dermatitis.
- •Subjects who have an active viral skin infection.
- •Subjects with a current or history of malignancy.
研究组 & 干预措施
0.3% OPA-15406
Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily.
干预措施: OPA-15406 (Drug)
1% OPA-15406
Subjects were treated with assigned 1% OPA-15406 ointment twice daily.
干预措施: OPA-15406 (Drug)
Placebo
Subjects were treated with assigned 0% OPA-15406 ointment twice daily.
干预措施: Placebo (Drug)
结局指标
主要结局
Responder Rate of Investigator's Global Assessment(IGA) of Disease Severity at Week4
时间窗: At Week 4
The investigator or sub investigator assessed the skin symptoms using IGA. The investigator or sub investigator scored the severity (0 = clear, 1 = almost clear, 2 =mild, 3 = moderate, 4 = severe/very severe) of the overall symptoms of the treatment area (erythema, infiltration, papules, effusion and scab formation) from baseline to Week4. Incidence of success in IGA was defined as the rate of subjects whose IGA score was 0 (clear) or 1 (almost clear) and had improved by at least 2 grades (responders) from baseline.
次要结局
- Change From Baseline in Percentage Affected Body Surface Area(Baseline, Week 4)
- Mean (SD) Normalized OPA-15406 Plasma Trough Concentrations by Dose Derived From %BSA(Week1, Week4, Week8)
- Change From Baseline in Eczema Area and Severity Index (EASI) Score(Baseline, Week 4)
- Mean (SD) OPA-15406 Plasma Trough Concentrations(Week1, Week4, Week8)
- Change From Baseline in Verbal Rating Scale(VRS) for Pruritus Score(Baseline, Hour 156)
- Change From Baseline in Patient-Oriented Eczema Measure(POEM) Score(Baseline, Week 4)
- OPA-15406 Plasma PK Parameters, Cmax(Day 1 and Week 4)
- Change From Baseline in Visual Analogue Scale(VAS) for Pruritus Score(Baseline, Week 4)
- OPA-15406 Plasma PK Parameters, AUC8h(Day 1 and Week 4)