Pediatric Microbiome Study With Children Now Approximately 8-10 Years Old.

Completed

• Conditions: Healthy Volunteers

• Registration Number: NCT03485755
• Lead Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)

Brief Summary

Single site study involving Biological Mothers and their children approximately 8-10 years old to assess the predominant microflora and skin physiology.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-08
• Study Start: 2018-03-12
• Primary Completion: 2018-03-23
• Study Completion: 2018-03-23
• Study First Submitted QC: 2018-03-26
• Study First Posted: 2018-04-02
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-22
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Must be the biological mother of a child (approximately age 8-10 years) enrolled in the study
• All subjects are to have normal healthy skin and no presence of pre-existing or dormant dermatologic skin conditions;
• Willing to use only the provided cleansing product during the washout time period;
• Willing to refrain from topical product use on the skin for the duration of the study. Topical products that should not be used include moisturizers, lotions, sunscreens, oils, tanners;
• Willing to refrain from swimming, using hot tubs, excessive sun exposure or tanning beds during the course of this study;

Exclusion Criteria

• Presents with a skin condition that may influence the outcome of the study (specifically psoriasis, eczema, atopic dermatitis, cutaneous xerosis, erythema, active skin cancer) a

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Microbial Community Diversity for Children	Day 1	Swabs will be collected from the volar forearm, forehead and cheek for analysis based on the Shannon Index

Secondary Outcome Measures

Name	Time	Method
Microbial Community Richness for Adults	Day 1	swabs will be collected from the volar forearm, forehead and cheek for analysis to determine the total number of different bacterial taxa detected
Skin pH	Day 1	skin pH will be assessed by pH meter
Microbial Community Diversity for Adults	Day 1	swabs will be collected from the volar forearm, forehead and cheek for analysis based on the Shannon Index
Microbial Community Richness for Children	Day 1	swabs will be collected from the skin for analysis to determine the total number of different bacterial taxa detected
Skin Barrier Function	Day 1	Trans Epidermal Water Loss (TEWL) will be used to assess the skin barrier function

Trial Locations

Locations (1)

Consumer Experience Center; 🇺🇸 Skillman, New Jersey, United States