NCT00731042已完成4 期
A Two-week Crossover Evaluation of Two Hand Antiseptic Products on Skin Condition in Healthy Human Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 33
- 主要终点
- Change From Baseline in Skin Health, Visual Skin Score (VSS) at 14 Days
研究概览
简要总结
Evaluate the effect of two hand antiseptic products on hand skin conditions of healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female age 25 - 55
- •Subject agrees not to use any hand wash products on their hands other than what has been provided in the study.
- •Subject agrees not to use any moisturizers or any skin products on their hands during the study
- •Subject agrees to use gloves to protect hands from activities such as dish washing
- •Subject is willing to sign the Informed Consent and HIPAA
- •Subject agrees to comply with the study requirement
排除标准
- •Subject has a history of psoriasis, active dermatitis, skin reactions, cracked, irritated, broken skin, skin infection on their hands
- •Subject has scaly skin on hands based on Visual Scoring Scale at Day 1
- •Subject has a sensitivity or history of skin reactions to any study materials (eg, alcohol, chlorhexidine gluconate or zinc pyrithone or latex in the gloves)
- •Subject has been using moisturizing products or any products on their arms and hands within 5 days prior to participation in the study
- •Subject is pregnant
- •Study coordinator believes the subject is unsuitable for inclusion in the study
研究组 & 干预措施
Avagard
Experimental
3M Avagard Surgical and healthcare Personnel Hand Antiseptic with Moisturizers
干预措施: Avagard (Drug)
Purell
Active Comparator
Purell Surgical Scrub with Moisturizers
干预措施: Purell Surgical Scrub (Drug)
结局指标
主要结局
Change From Baseline in Skin Health, Visual Skin Score (VSS) at 14 Days
时间窗: Baseline and 14 days
Observe VSS score at 14 days, and graded change of skin health from baseline using scale of 0 (normal) - 5 (very scaly).
次要结局
未报告次要终点
研究者
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