A Phase 3, Multicenter, Open-label, Uncontrolled Trial to Evaluate the Efficacy and Safety of OPA-15406 Ointment in Infants Younger Than 2 Years of Age With Atopic Dermatitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Success Rate in IGA (Percentage of Subjects With an IGA Score of 0 or 1 With Improvement by at Least 2 Grades)
研究概览
简要总结
To investigate the efficacy of 0.3% OPA-15406 ointment when administered twice daily for 4 weeks in infants younger than 2 years of age with Atopic Dermatitis
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are diagnosed with AD in accordance with the criteria of the Japanese Dermatological Association
- •Subjects whose AD affects 5% to 40% of BSA (excluding scalp) at the screening and baseline examinations
- •Subjects who have an 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
OPA-15406
干预措施: OPA-15406 (Drug)
结局指标
主要结局
Success Rate in IGA (Percentage of Subjects With an IGA Score of 0 or 1 With Improvement by at Least 2 Grades)
时间窗: Week 4
The investigator or sub investigator assessed the skin symptoms using IGA (Investigator's Global Assessment). 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 Week 4. Incidence of success in IGA was defined as the rate of subjects whose IGA score is 0 (clear) or 1 (almost clear) and had improved by at least 2 grades (responders) from baseline.
次要结局
- Response Rate in Eczema Area and Severity Index (EASI) 75 (Improvement of ≥75% in EASI)(Week4)