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

Healthy Volunteers Clinical Trial

Official title:

The Evolution of the Skin Microbiome of Children Approximately Ages 8-10 Years of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03485755
• Other study ID #: CCSSKA000104
• Status: Completed
• Start date: March 12, 2018
• Est. completion date: March 23, 2018

Study information

• Verified date: March 2019
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 23, 2018
• Est. primary completion date: March 23, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Locations

Country	Name	City	State
United States	Consumer Experience Center	Skillman	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Consumer Inc. (J&JCI)

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Redacted Clinical Study Report