DermatitisNCT03242577
Micro-Technique Sampling
An observational study of Dermatitis, run by Kimberly-Clark Corporation at 1 site in United States.
Trial summary
This is a single-center, exploratory comparative pilot study to identify the most appropriate method for microbial consortia sampling from the skin. Ten subjects are expected to complete the study at one investigative site in the United States. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Dermatitis
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 2 Aug 2017
- 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 18 to 40 years
- Women only
- Adult
Study population: Subjects will consist of ten (10)Caucasian female adults 18-40 years of age, at 1 US site.
Who may be able to join
- Fluent in English, willing and able to read, understand, and sign the informed consent form (ICF);
- Ability to complete the course of the study and comply with instructions;
- Females aged 18 to 40 years, in good general health as deemed by the investigator (no physical required);
- Individuals free of any systemic or dermatological disorder, tatoos in the testing area or recent tanning bed exposure
- Anticipated ability to complete the course of the study and to comply with instructions;
- Females practicing an acceptable method of birth control
- Caucasian individuals with Fitzpatrick skin type I, II, or III
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Reliance Clinical Testing Services
Irving, Texas, 75062
About this study
Official title: An Exploratory Comparative Pilot Study to Identify the Most Appropriate Method for Microbial Consortia Sampling From the Skin-II
This is a single-center, exploratory comparative pilot study to identify the most appropriate method for microbial consortia sampling from the skin.
Ten subjects are expected to complete the study at one investigative site in the United States.
The study will consist of 2 visits, Visit 1 (Screening), Visit 2 (Sampling). At Visit 1, subjects will be consented and have their eligibility reviewed. Visit 1 and Visit 2 may be combined into one visit. Visit 1 will involve the informed consent process, screening, and enrollment. Visit 2 will involve sampling of eight (8) test sites on the back with three (3) different sampling methods: swabbing (2 sites/method), cup scrub (2 sites/method), and tape stripping (4 sites/method). All samples will be returned to Kimberly Clark then sent to a laboratory for analysis.
- Conditions
- Dermatitis
- Medical subject headings
- Dermatitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Best method for collecting skin microbiome samples
Composition of skin microbiome by 16SrRNA pyrosequencing from 3 skin collection methods: Swabbing; Cup Scrub; and Tape Stripping
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study start1 Aug 2017
- Primary completion2 Aug 2017
- Study completion2 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermatitisStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kimberly-Clark Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barry Reece, Principal investigator, RCTs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03242577
- Sponsor's protocol ID
- 500-17-07
- Status last verified
- Oct 2017
- First submitted
- 3 Aug 2017
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Subjects will be identified on logs and other documents submitted to the Sponsor by their unique identification number with or without their initials, not by name. Documents that identify the subject (e.g., the signed informed consent) are not to be submitted to the Sponsor and must be maintained in confidence by the Investigator.
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Comparative Pilot Study to Identify the Most Appropriate Method for Microbial Consortia Sampling From the Skin-II
- ClinicalTrials.gov ID
- NCT03242577
- Acronym / sponsor ID
- 500-17-07
- Conditions
- Dermatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Kimberly-Clark CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 2 Aug 2017 (actual)
- Study completion
- 2 Aug 2017 (actual)
- First posted
- 8 Aug 2017 (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.
This is a single-center, exploratory comparative pilot study to identify the most appropriate method for microbial consortia sampling from the skin.
Ten subjects are expected to complete the study at one investigative site in the United States.
The study will consist of 2 visits, Visit 1 (Screening), Visit 2 (Sampling). At Visit 1, subjects will be consented and have their eligibility reviewed. Visit 1 and Visit 2 may be combined into one visit. Visit 1 will involve the informed consent process, screening, and enrollment. Visit 2 will involve sampling of eight (8) test sites on the back with three (3) different sampling methods: swabbing (2 sites/method), cup scrub (2 sites/method), and tape stripping (4 sites/method). All samples will be returned to Kimberly Clark then sent to a laboratory for analysis.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Subjects will consist of ten (10)Caucasian female adults 18-40 years of age, at 1 US site.
Key inclusion criteria (7 listed)
- Fluent in English, willing and able to read, understand, and sign the informed consent form (ICF);
- Ability to complete the course of the study and comply with instructions;
- Females aged 18 to 40 years, in good general health as deemed by the investigator (no physical required);
- Individuals free of any systemic or dermatological disorder, tatoos in the testing area or recent tanning bed exposure
- Anticipated ability to complete the course of the study and to comply with instructions;
Key exclusion criteria (0 listed)
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
Best method for collecting skin microbiome samples
Time frame: 1 day
Composition of skin microbiome by 16SrRNA pyrosequencing from 3 skin collection methods: Swabbing; Cup Scrub; and Tape Stripping
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 1 Nov 2017.
- Individual participant dataSharing planned: No. Subjects will be identified on logs and other documents submitted to the Sponsor by their unique identification number with or without their initials, not by name. Documents that identify the subject (e.g., the signed informed consent) are not to be submitted to the Sponsor and must be maintained in confidence by the Investigator.
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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.
Barry Reece principal investigator
RCTs
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 Dermatitis, run by Kimberly-Clark Corporation 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 7 inclusion and 0 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 1 Nov 2017. 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?
Best method for collecting skin microbiome samples (time frame: 1 day). 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 1 Nov 2017; AzTrials last refreshed its copy on 29 Oct 2026.