NCT00839462已完成2 期
Evaluation of the Effect of Bepanthen Burn Relief Foam Spray New Formula on a Thermic Erythema. 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
- 55
- 主要终点
- Global sum of scores for evaluating the cooling/soothing effect evaluated after first and second application
研究概览
简要总结
The study focuses to prove the equivalent efficacy 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
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 known allergy to cosmetics, skin care products, or topical drugs, a sensitivity related to any component of any formulations being tested
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
Global sum of scores for evaluating the cooling/soothing effect evaluated after first and second application
时间窗: 2 min, 5 min, 10 min, 15 min
次要结局
- Skin temperature(2 min, 5 min, 10 min)
- Evaluation of the cooling/soothing effect (scores) after first and second application(2 min, 5min, 10 min, 15 min)
- Evaluation of the foam covering properties after first application(2 min, 5 min, 10 min, 15 min)
- Incidence of adverse events(FPFV - LPLV)
研究者
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