NCT05608382已完成不适用
Effect of an Antiseptic Solution on the Skin Microbiome
Center for Innovation and Research Organization2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年3月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Colony Forming Unit (CFU) count
研究概览
简要总结
The objective of this study is simulate the clinical use of an antiseptic solution in a 24 hour window and the recovery to baseline conditions at 1 month following application. Efficacy will be simulated as the capacity of the material to reduce or clear the skin bacterial population from a representative skin area: the anteromedial forearm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A subject may be eligible for study participation if all of the following criteria are met:
- •Subject is male or female greater than 18 years of age.
- •Subject does not have a history of skin allergies/atopia (e.g. atopic dermatitis).
- •Subject does not have a history of skin disease (e.g scleroderma, vitiligo, psoriasis) or a chronic systemic disease affecting the skin (e.g systemic lupus erythematosus).
- •Subject is willing to have materials applied and follow the protocol.
- •Subject agrees to avoid exposure of the test sites to the sun, chemical product, clothes and to refrain from touching the area of application (for T0 [baseline], T1 [5 minutes], T2 [2 hours]).
- •Subject agrees to refrain from getting a bath/shower before T3 (24 h).
- •Subject agrees to avoid scrubbing, applying, and/or washing the test area with new soap, moistures, powders, lotions, cosmetic or toiletry products during the study.
- •Subject is able to follow directions as outlined in the protocol and anticipates being available for all study visits.
- •Subject is willing to participate in all study evaluations.
- •Subject is in generally good health.
- •Subject is willing to sign the Informed Consent form prior to study participation
排除标准
- •Female subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control.
- •Subject is immunologically compromised or has received specific topical treatment (antimicrobial or not-antimicrobial), during the last month.
- •Subject reports a history of allergies to antiseptics.
- •Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study.
- •Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs.
结局指标
主要结局
Colony Forming Unit (CFU) count
时间窗: 24 hours
Comparison of the number of CFUs counted for each treatment arm
次要结局
未报告次要终点
研究者
研究点 (2)
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