NCT07173478尚未招募3 期
A Multicenter, Randomized, Double-blind, Vehicle-controlled, Parallel-group Comparison Trial to Demonstrate the Superiority of 1% OPA-15406 Foam to the Vehicle in Adult Patients With Atopic Dermatitis (Phase 3 Trial)
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Success rate in Investigator's Global Assessment (IGA)
研究概览
简要总结
To investigate the superiority of 1% OPA-15406 foam to the vehicle in adult 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
- 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
- •Participants who have been diagnosed AD based on the Diagnostic Criteria for Atopic Dermatitis (Criteria of the Japanese Dermatological Association)
- •Participants with a history of AD for at least 3 years
- •Participants who have an affected area covering from 5% to 40% of their body surface area (excluding the scalp) at the screening and baseline examinations
- •Participants with an IGA score of 2 or 3 at the screening and baseline examinations
排除标准
- •Participants who experienced an acute exacerbation of AD or contact dermatitis within 28 days prior to the baseline examination
- •Participants who have been treated with OPA-15406 ointment in the past
研究组 & 干预措施
1% OPA-15406 foam
Experimental
干预措施: OPA-15406 (Drug)
Vehicle
Experimental
干预措施: Vehicle (Drug)
结局指标
主要结局
Success rate in Investigator's Global Assessment (IGA)
时间窗: 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 participants 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
未报告次要终点
研究者
研究点 (1)
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