Micro-Technique Sampling

Kimberly-Clark

Status: Completed

Conditions: Dermatitis

Study type: Observational

Funder types: Industry

Identifiers

NCT03242577

500-17-07

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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