Micro-Technique Sampling

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-01

Study Completion Date

2017-08-02

Brief Summary

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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.

Detailed Description

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Conditions

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Dermatitis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Barry Reece

Role: PRINCIPAL_INVESTIGATOR

RCTs

Locations

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Reliance Clinical Testing Services

Irving, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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500-17-07

Identifier Type: -

Identifier Source: org_study_id