Healthy VolunteersNCT03485755
Pediatric Microbiome Study With Children Now Approximately 8-10 Years Old.
An observational study of Healthy Volunteers, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.
Trial summary
Single site study involving Biological Mothers and their children approximately 8-10 years old to assess the predominant microflora and skin physiology. Read more about this study
- Who is it for?
- Ages 8 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2018to 23 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children and their biological mothers
Who may be able to join
- 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;
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Consumer Experience Center
Skillman, New Jersey, 08558
About this study
Official title: The Evolution of the Skin Microbiome of Children Approximately Ages 8-10 Years of Age
Single site study involving Biological Mothers and their children approximately 8-10 years old to assess the predominant microflora and skin physiology.
- Conditions
- Healthy Volunteers
- Keywords
- microflora, microbiome, bacteria taxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children | Children 8-10 years of age | |
| Biological Mothers | Biological mothers of children now ages 8-10 years of age |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbial Community Diversity for Children
Swabs will be collected from the volar forearm, forehead and cheek for analysis based on the Shannon Index
Measured: Day 1
Secondary outcomes (5)
Microbial Community Diversity for Adults
swabs will be collected from the volar forearm, forehead and cheek for analysis based on the Shannon Index
Measured: Day 1
Microbial Community Richness for Children
swabs will be collected from the skin for analysis to determine the total number of different bacterial taxa detected
Measured: Day 1
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
Measured: Day 1
Skin Barrier Function
Trans Epidermal Water Loss (TEWL) will be used to assess the skin barrier function
Measured: Day 1
Skin pH
skin pH will be assessed by pH meter
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start12 Mar 2018
- Primary completion23 Mar 2018
- Study completion23 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruce L Moskovitz, MD, Principal investigator, Bruce L Moskovitz MD - private consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485755
- Sponsor's protocol ID
- CCSSKA000104
- Status last verified
- Mar 2019
- First submitted
- 8 Mar 2018
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evolution of the Skin Microbiome of Children Approximately Ages 8-10 Years of Age
- ClinicalTrials.gov ID
- NCT03485755
- Acronym / sponsor ID
- CCSSKA000104
- Conditions
- Healthy Volunteers
- Keywords
- microflora, microbiome, bacteria taxa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)Industry (pharma, biotech, devices)
- Study start
- 12 Mar 2018 (actual)
- Primary completion
- 23 Mar 2018 (actual)
- Study completion
- 23 Mar 2018 (actual)
- First posted
- 2 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single site study involving Biological Mothers and their children approximately 8-10 years old to assess the predominant microflora and skin physiology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children | – | –Children 8-10 years of age |
| Biological Mothers | – | –Biological mothers of children now ages 8-10 years of age |
Who may qualify
- Ages
- 8 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children and their biological mothers
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
Microbial Community Diversity for Adults
Time frame: Day 1
Microbial Community Richness for Children
Time frame: Day 1
Microbial Community Richness for Adults
Time frame: Day 1
Skin Barrier Function
Time frame: Day 1
Skin pH
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Redacted Clinical Study ReportLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce L Moskovitz, MD principal investigator
Bruce L Moskovitz MD - private consultant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbial Community Diversity for Children (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019.