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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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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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Subjects will consist of ten (10)Caucasian female adults 18-40 years of age, at 1 US site.
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| Name | Affiliation | Role |
|---|---|---|
| Barry Reece | RCTs | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reliance Clinical Testing Services | Irving | Texas | 75062 | United States |
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.
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| ID | Term |
|---|---|
| D003872 | Dermatitis |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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