A Multicenter, Randomized, Double-blind, Vehicle-controlled, Parallel-group Trial to Assess the Safety and Efficacy of 0.3% and 1% OPA-15406 Ointments When Administered for 4 Weeks in Pediatric Patients With Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 73
- 主要终点
- The Number of Subjects Experiencing AEs
研究概览
简要总结
To evaluate the safety, efficacy (dose response) and pharmacokinetics of 0.3% and 1% OPA-15406 when applied twice daily for 4 weeks in pediatric 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
- 2 Years 至 14 Years（Child）
- 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
Placebo Ointments
Subjects were treated with assigned 0% OPA-15406 ointment twice daily.
干预措施: Placebos (Drug)
0.3% OPA-15406 Ointments
Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily.
干预措施: OPA-15406 (Drug)
1% OPA-15406 Ointments
Subjects were treated with assigned 1% OPA-15406 ointment twice daily.
干预措施: OPA-15406 (Drug)
结局指标
主要结局
The Number of Subjects Experiencing AEs
时间窗: Week 0-4
The number of subjects experiencing AEs will be calculated for each treatment group. Treatment-emergent adverse events (TEAEs) occurring after the start of IMP administration are summarized. The number of subjects with events, the number of events is obtained for all the TEAEs reported.
次要结局
- Responder Rate of Investigator's Global Assessment(IGA) of Disease Severity at Week4(Baseline and Week 4)
- Change From Baseline in Eczema Area and Severity Index (EASI) Score(Baseline, Week 4)
- Change From Baseline in Visual Analogue Scale(VAS) for Pruritus Score(Baseline, Week 4)
- 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)
- Change From Baseline in Percentage Affected Body Surface Area(Baseline, Week 8, 16, 24)
- Mean (SD) OPA-15406 Plasma Trough Concentrations at week1(Week 1)
- Mean (SD) OPA-15406 Plasma Trough Concentrations at week4(week4)
- Mean (SD) Normalized OPA-15406 Plasma Trough Concentrations by Dose Derived From %BSA at week1(week1)
- Mean (SD) Normalized OPA-15406 Plasma Trough Concentrations by Dose Derived From %BSA at week4(week4)