Micro-Technique Sampling

Completed

• Conditions: Dermatitis

• Registration Number: NCT03242577
• Lead Sponsor: Kimberly-Clark Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-01
• Primary Completion: 2017-08-02
• Study Completion: 2017-08-02
• Study First Submitted: 2017-08-03
• Study First Submitted QC: 2017-08-03
• Study First Posted: 2017-08-08
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-30
• Last Update Posted: 2017-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

• 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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Best method for collecting skin microbiome samples	1 day	Composition of skin microbiome by 16SrRNA pyrosequencing from 3 skin collection methods: Swabbing; Cup Scrub; and Tape Stripping

Trial Locations

Locations (1)

Reliance Clinical Testing Services; 🇺🇸 Irving, Texas, United States