Micro-Technique Sampling

Dermatitis Clinical Trial

Official title:

An Exploratory Comparative Pilot Study to Identify the Most Appropriate Method for Microbial Consortia Sampling From the Skin-II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03242577
• Other study ID #: 500-17-07
• Status: Completed
• Phase: N/A
• First received: August 3, 2017
• Last updated: October 30, 2017
• Start date: August 1, 2017
• Est. completion date: August 2, 2017

Study information

• Verified date: October 2017
• Source: Kimberly-Clark Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2, 2017
• Est. primary completion date: August 2, 2017
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis

Locations

Country	Name	City	State
United States	Reliance Clinical Testing Services	Irving	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Kimberly-Clark Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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