Micro-Technique Sampling
| Status: | Completed |
|---|---|
| Conditions: | Psoriasis, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - 40 |
| Updated: | 11/3/2017 |
| Start Date: | August 1, 2017 |
| End Date: | August 2, 2017 |
An Exploratory Comparative Pilot Study to Identify the Most Appropriate Method for Microbial Consortia Sampling From the Skin-II
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.
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.
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
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