NCT00839280已完成2 期
Evaluation of the Moisturizing Effect of Bepanthen Burn Relief Foam Spray New Formula Versus Bepanthen Burn Relief Foam Spray (Current Formula). Equivalence Trial. Intra-individual Design.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 19
- 主要终点
- Area Under Curve (AUC) of the cutaneous hydration rate measured with corneometer between T0 and T5h
研究概览
简要总结
The study focuses to prove the equivalent moisturizing effect of two different Dexpanthenol formulations
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects
- •Phototype: I to IV according to Fitzpatrick scale
- •Subjects with dry skin on their forearms
排除标准
- •Pregnant or nursing women
- •Subjects registered as being in exclusion period in the French Health Minister file of subjects
- •Subjects with hypersensitivity to one of the test products
研究组 & 干预措施
Arm 1
Experimental
干预措施: Dexpanthenol foam spray, new formulation (Drug)
Arm 2
Active Comparator
干预措施: Dexpanthenol foam spray, old formulation (Drug)
结局指标
主要结局
Area Under Curve (AUC) of the cutaneous hydration rate measured with corneometer between T0 and T5h
时间窗: 0 min, 15 min, 30 min, 1h, 2h, 3h, 5h
次要结局
- Cutaneous hydration rate(15 min, 30 min, 1h, 2h, 3h, 5h)
- Incidence of Adverse Events(FPFV - LPLV)
研究者
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