NCT03485755

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

March 12, 2018

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 2, 2018

Completed
Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

11 days

First QC Date

March 8, 2018

Last Update Submit

March 22, 2019

Conditions

Healthy Volunteers

Keywords

microfloramicrobiomebacteria taxa

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Microbial Community Diversity for Adults

    Day 1

  • Microbial Community Richness for Children

    Day 1

  • Microbial Community Richness for Adults

    Day 1

  • Skin Barrier Function

    Day 1

  • Skin pH

    Day 1

Study Arms (2)

Children

Children 8-10 years of age

Biological Mothers

Biological mothers of children now ages 8-10 years of age

Eligibility Criteria

Age8 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children and their biological mothers

You may qualify if:

  • 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;

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Consumer Experience Center

Skillman, New Jersey, 08558, United States

Location

Related Links

Study Officials

  • Bruce L Moskovitz, MD

    Bruce L Moskovitz MD - private consultant

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2018

First Posted

April 2, 2018

Study Start

March 12, 2018

Primary Completion

March 23, 2018

Study Completion

March 23, 2018

Last Updated

March 26, 2019

Record last verified: 2019-03

Locations

US(1)