NCT05617729已完成不适用
A Clinical Simulation Study of a Test Material on the Anterior Nares
Center for Innovation and Research Organization1 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
干预措施
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
- 1
- 主要终点
- Colony Forming Units
研究概览
简要总结
The objective of this study is simulate the clinical use of a test material within a 24h window. Efficacy will be simulated as the capacity of the material to reduce or clear the anterior nares bacterial population from opportunistic pathogens (e.g. Staphylococcus Aureus, Escherichia Coli, etc).
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
- 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
- 是
入选标准
- •Subject is male or female between 18 to 55 years of age;
- •Subject has normal nasal passage;
- •Subject has not history of chronic nasal passage disease (chronic rhinitis, chronic sinusitis).
- •Subject is willing to have materials applied and follow the protocol;
- •Subject agrees to avoid exposure of the test sites to any chemical product and to refrain from touching the area of application.
- •Subject agrees to refrain from getting the application site wet and scrubbing or washing the test area with soap or applying powders, lotions or personal care products to the area during the course of the study;
- •Subject agrees not to introduce any new cosmetic or toiletry products during the study;
- •Subject is dependable and 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 understands and is willing to sign an Informed Consent Form
排除标准
- •Female subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control;
- •Subject has a chronic nasal disease (e.g sinusitis, rhinitis);
- •Subject has a bleeding disorder, immunologically compromised, recent illness/vaccination or currently febrile;
- •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
研究组 & 干预措施
Saline
Placebo Comparator
this treatment consists of sterile saline that is applied to the nares using a swab
干预措施: Saline applied via swab (Other)
Povidone-iodine based gel
Active Comparator
this treatment consists of a Povidone-Iodine based gel that is applied to the nares using a swab
干预措施: Povidone-iodine based gel (Other)
结局指标
主要结局
Colony Forming Units
时间窗: up to 24 hours following application
次要结局
未报告次要终点
研究者
研究点 (1)
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