An Exploratory Comparative Pilot Study to Identify the Most Appropriate Method for Microbial Consortia Sampling From the Skin-II
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Best method for collecting skin microbiome samples
研究概览
简要总结
This is a single-center, exploratory comparative pilot study to identify the most appropriate method for microbial consortia sampling from the skin.
Ten subjects are expected to complete the study at one investigative site in the United States.
The study will consist of 2 visits, Visit 1 (Screening), Visit 2 (Sampling). At Visit 1, subjects will be consented and have their eligibility reviewed. Visit 1 and Visit 2 may be combined into one visit. Visit 1 will involve the informed consent process, screening, and enrollment. Visit 2 will involve sampling of eight (8) test sites on the back with three (3) different sampling methods: swabbing (2 sites/method), cup scrub (2 sites/method), and tape stripping (4 sites/method). All samples will be returned to Kimberly Clark then sent to a laboratory for analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Fluent in English, willing and able to read, understand, and sign the informed consent form (ICF);
- •Ability to complete the course of the study and comply with instructions;
- •Females aged 18 to 40 years, in good general health as deemed by the investigator (no physical required);
- •Individuals free of any systemic or dermatological disorder, tatoos in the testing area or recent tanning bed exposure
- •Anticipated ability to complete the course of the study and to comply with instructions;
- •Females practicing an acceptable method of birth control
- •Caucasian individuals with Fitzpatrick skin type I, II, or III
排除标准
- 未提供
结局指标
主要结局
Best method for collecting skin microbiome samples
时间窗: 1 day
Composition of skin microbiome by 16SrRNA pyrosequencing from 3 skin collection methods: Swabbing; Cup Scrub; and Tape Stripping
次要结局
未报告次要终点