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OpenTrials
Completed

NCT Number: NCT03242577

Micro-Technique Sampling

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.

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Key information

Conditions

Dermatitis Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Reliance Clinical Testing Services

Irving, Texas, 75062, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Best method for collecting skin microbiome samples

    Time frame: 1 day

    Composition of skin microbiome by 16SrRNA pyrosequencing from 3 skin collection methods: Swabbing; Cup Scrub; and Tape Stripping

Sponsors and collaborators

Lead sponsor

Kimberly-Clark Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 8, 2017
Registry last updated
Nov 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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