NCT02376049已完成1 期
An Explorative Clinical Trial to Evaluate an Intra Patient Comparison Design of Topical Agents in Adults With Mild to Moderate Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Total Sign Score (TSS) change
研究概览
简要总结
An Explorative Clinical Trial to Evaluate an Intra Patient Comparison Design of Topical Agents in Adults with Mild to Moderate Atopic Dermatitis.
详细描述
Multi-center, prospective, randomized, vehicle-controlled, investigator-blinded, stable lesion design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject with mild to moderate AD
- •Four comparable TAs
- •TSS of at least 5 on all TAs
- •Difference in TSS not greater than 2 between the TAs
- •Sign score erythema ≥ 2 between the TAs
- •TAs should be at least 2 cm apart
排除标准
- •Investigator's opinion
- •Fitzpatrick skin type >5
- •Topical (i.e. on the TAs) treatment with prohibited medications
- •Systemic treatment with prohibited medications
- •Phototherapy within prohibited timeframe
- •Use of emollients within prohibited timeframe
研究组 & 干预措施
Betamethasone dipropionate cream
Active Comparator
Betamethasone dipropionate 0.05% cream once daily for 14 days
干预措施: Betamethasone dipropionate cream (Drug)
Pimecrolimus cream
Active Comparator
Pimecrolimus 1% cream once daily for 14 days
干预措施: Pimecrolimus cream (Drug)
Clobetasol propionate cream
Active Comparator
Clobetasol propionate 0.05% cream once daily for 14 days
干预措施: Clobetasol propionate cream (Drug)
Glaxal Base cream vehicle
Placebo Comparator
Glaxal Base cream vehicle once daily for 14 days
干预措施: Glaxal Base cream vehicle (Drug)
结局指标
主要结局
Total Sign Score (TSS) change
时间窗: 14 days
TSS change at end of treatment in relation to baseline
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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