跳至主要内容
临床试验/NCT07184645
NCT07184645尚未招募3 期

A Multicenter, Randomized, Double-blind, Vehicle-controlled, Parallel-group Comparison Trial to Demonstrate the Superiority of 0.3% OPA-15406 Foam to the Vehicle in Children With Atopic Dermatitis in Combination With an Open-label, Uncontrolled Trial to Evaluate the Safety and Efficacy of 0.3% and 1% OPA-15406 Foam in Infants Under 2 Years of Age and Children With Atopic Dermatitis (Phase 3 Trial)

Otsuka Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2025年9月1日最近更新:
干预措施

试验速览

阶段
3 期
状态
尚未招募
入组人数
198
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 0.3% OPA-15406 foam to the vehicle in children 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
3 Months 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Participants who have been diagnosed with AD based on the Diagnostic Criteria for Atopic Dermatitis (Criteria of the Japanese Dermatological Association)
  • 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

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

申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验