Micro-Technique Sampling
An Exploratory Comparative Pilot Study to Identify the Most Appropriate Method for Microbial Consortia Sampling From the Skin-II
1 other identifier
observational
10
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 2, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 2, 2017
CompletedFirst Submitted
Initial submission to the registry
August 3, 2017
CompletedFirst Posted
Study publicly available on registry
August 8, 2017
CompletedNovember 1, 2017
October 1, 2017
1 day
August 3, 2017
October 30, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Best method for collecting skin microbiome samples
Composition of skin microbiome by 16SrRNA pyrosequencing from 3 skin collection methods: Swabbing; Cup Scrub; and Tape Stripping
1 day
Eligibility Criteria
Subjects will consist of ten (10)Caucasian female adults 18-40 years of age, at 1 US site.
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Reliance Clinical Testing Services
Irving, Texas, 75062, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barry Reece
RCTs
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2017
First Posted
August 8, 2017
Study Start
August 1, 2017
Primary Completion
August 2, 2017
Study Completion
August 2, 2017
Last Updated
November 1, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share
Subjects will be identified on logs and other documents submitted to the Sponsor by their unique identification number with or without their initials, not by name. Documents that identify the subject (e.g., the signed informed consent) are not to be submitted to the Sponsor and must be maintained in confidence by the Investigator.