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Completed

NCT Number: NCT03485755

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

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

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Key information

Conditions

Healthy Volunteers

Age range

8 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Consumer Experience Center

Skillman, New Jersey, 08558, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Microbial Community Diversity for Children

    Time frame: Day 1

    Swabs will be collected from the volar forearm, forehead and cheek for analysis based on the Shannon Index

Secondary outcomes

  1. Microbial Community Diversity for Adults

    Time frame: Day 1

    swabs will be collected from the volar forearm, forehead and cheek for analysis based on the Shannon Index

  2. Microbial Community Richness for Children

    Time frame: Day 1

    swabs will be collected from the skin for analysis to determine the total number of different bacterial taxa detected

  3. Microbial Community Richness for Adults

    Time frame: 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

  4. Skin Barrier Function

    Time frame: Day 1

    Trans Epidermal Water Loss (TEWL) will be used to assess the skin barrier function

  5. Skin pH

    Time frame: Day 1

    skin pH will be assessed by pH meter

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Consumer Inc. (J&JCI)

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 2, 2018
Registry last updated
Mar 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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