A Multicenter, Randomized, Double-blind, Vehicle Controlled, Parallel-group Comparison Trial to Demonstrate the Superiority of 0.3% and 1% OPA-15406 Ointment to the Vehicle in Pediatric Patients With Atopic Dermatitis (Phase 3 Trial)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 251
- 试验地点
- 1
- 主要终点
- Responder Rate of Investigator's Global Assesment (IGA) of Disease Severity
研究概览
简要总结
To demonstrate the superiority of the investigational medicinal product (IMP; 0.3% OPA-15406 ointment, 1% OPA-15406 ointment, or vehicle) to the vehicle when administered twice daily for 4 weeks using success rate in Investigator's Global Assessment (IGA) at Week 4 as the primary endpoint in pediatric patients with Atopic Dermatitis (AD).
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, Care Provider, Investigator)
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 AD based on the Japanese Dermatological Association's criteria
- •Atopic dermatitis affecting more than or equal to 5%, to less than or equal to 40% of body surface area (BSA, excluding scalp) at the screening and baseline examinations
- •IGA score of 2 or 3 at the screening and baseline examinations
排除标准
- •Subjects who have an AD or contact dermatitis flare-up defined as a rapid intensification of AD, within 28 days prior to the baseline examination
研究组 & 干预措施
0.3% OPA-15406
Twice daily
干预措施: 0.3% OPA-15406 (Drug)
1% OPA-15406
Twice daily
干预措施: 1% OPA-15406 (Drug)
Placebo
Twice daily
干预措施: Placebos (Drug)
结局指标
主要结局
Responder Rate of Investigator's Global Assesment (IGA) of Disease Severity
时间窗: At Week 4
The investigator or subinvestigator assessed the skin symptoms using IGA. The investigator or subinvestigator 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 Week 4. Incidence of success in IGA is defined as the rate of subjects whose IGA score is 0 (clear) or 1 (almost clear) and has improved by at least 2 grades (responders) from baseline.
次要结局
- Change From Baseline in Eczema Area and Severity Index (EASI) Score(Baseline, Week 4)
- Change From Baseline in Verbal Rating Scale (VRS) for Pruritus Score(Baseline, Week 4)