- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03112876
Sebum Collection and Skin Barrier Function Analysis (Sebum)
April 7, 2017 updated by: University of California, Davis
Sebum Collection for Analysis and Correlation to Sebum Production, Barrier Function, and With Cutaneous and Internal Inflammatory Disease
The goal is this study is to evaluate how the skin surface lipid composition is correlated with overall sebum production, barrier function, and inflammatory disease status. We hypothesize that there will be differences in the skin surface composition among subjects of various groups:
- Young vs older healthy population
- Atopic dermatitis vs Acne vs Healthy controls
- Active smokers vs non-smoker controls
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study will be conducted through the use of painless tapes to collect lipid.
These will be applied to the skin and removed.
Secondly, the barrier function will be evaluated through the use of non-invasive painless devices that measure sebum, skin water loss, and skin hydration.
Study Type
Observational
Enrollment (Actual)
41
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Sacramento, California, United States, 95816
- UC Davis Department of Dermatology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Study patients will be recruited from the UC Davis Department of Dermatology, UC Davis undergraduate campus, Sacramento State University, and from the greater Sacramento area.
Description
Inclusion Criteria:
- Subjects that are 12 years of age or older
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Young Age - Healthy
These subjects are between the age of 12 and 35 years.
This group will undergo the following intervention: skin surface lipid collection via tapes and skin barrier function evaluated with non-invasive painless devices.
|
All five groups will undergo the same study intervention: skin surface lipid collection via tapes and skin barrier function evaluated with non-invasive painless devices.
Other Names:
|
|
Old Age -Healthy
These subjects are 55 years of age and older.
This group will undergo the following intervention: skin surface lipid collection via tapes and skin barrier function evaluated with non-invasive painless devices.
|
All five groups will undergo the same study intervention: skin surface lipid collection via tapes and skin barrier function evaluated with non-invasive painless devices.
Other Names:
|
|
Active Smoker
These subjects are active smokers who smoke often.
This group will undergo the following intervention: skin surface lipid collection via tapes and skin barrier function evaluated with non-invasive painless devices.
|
All five groups will undergo the same study intervention: skin surface lipid collection via tapes and skin barrier function evaluated with non-invasive painless devices.
Other Names:
|
|
Dermatological skin condition: Acne vulgaris
These subjects have acne vulgaris.
This group will undergo the following intervention: skin surface lipid collection via tapes and skin barrier function evaluated with non-invasive painless devices.
|
All five groups will undergo the same study intervention: skin surface lipid collection via tapes and skin barrier function evaluated with non-invasive painless devices.
Other Names:
|
|
Dermatological skin condition: Atopic dermatitis
These subjects have atopic dermatitis.
This group will undergo the following intervention: skin surface lipid collection via tapes and skin barrier function evaluated with non-invasive painless devices.
|
All five groups will undergo the same study intervention: skin surface lipid collection via tapes and skin barrier function evaluated with non-invasive painless devices.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lipid Profile-aging
Time Frame: 1 day
|
The lipid profile of the subject group will be evaluated through the use of painless tapes that will be applied to the skin.
|
1 day
|
|
Lipid Profile-acne
Time Frame: 1 day
|
The lipid profile of the subject group will be evaluated through the use of painless tapes that will be applied to the skin.
|
1 day
|
|
Lipid Profile-atopic dermatitis
Time Frame: 1 day
|
The lipid profile of the subject group will be evaluated through the use of painless tapes that will be applied to the skin.
|
1 day
|
|
Lipid Profile-smoking
Time Frame: 1 day
|
The lipid profile of the subject group will be evaluated through the use of painless tapes that will be applied to the skin.
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Skin Barrier Function- aging
Time Frame: 1 day
|
The skin barrier function will be evaluated for this group through the use of non-invasive handheld devices.
These devices provide information about sebum secretion rate, skin water loss, and skin hydration.
|
1 day
|
|
Skin Barrier Function- acne
Time Frame: 1 day
|
The skin barrier function will be evaluated for this group through the use of non-invasive handheld devices.
These devices provide information about sebum secretion rate, skin water loss, and skin hydration.
|
1 day
|
|
Skin Barrier Function- atopic dermatitis
Time Frame: 1 day
|
The skin barrier function will be evaluated for this group through the use of non-invasive handheld devices.
These devices provide information about sebum secretion rate, skin water loss, and skin hydration.
|
1 day
|
|
Skin Barrier Function- smoking
Time Frame: 1 day
|
The skin barrier function will be evaluated for this group through the use of non-invasive handheld devices.
These devices provide information about sebum secretion rate, skin water loss, and skin hydration.
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ni Raghallaigh S, Bender K, Lacey N, Brennan L, Powell FC. The fatty acid profile of the skin surface lipid layer in papulopustular rosacea. Br J Dermatol. 2012 Feb;166(2):279-87. doi: 10.1111/j.1365-2133.2011.10662.x.
- Sakai S, Kikuchi K, Satoh J, Tagami H, Inoue S. Functional properties of the stratum corneum in patients with diabetes mellitus: similarities to senile xerosis. Br J Dermatol. 2005 Aug;153(2):319-23. doi: 10.1111/j.1365-2133.2005.06756.x.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 27, 2014
Primary Completion (Actual)
February 26, 2016
Study Completion (Actual)
February 26, 2016
Study Registration Dates
First Submitted
July 10, 2014
First Submitted That Met QC Criteria
April 7, 2017
First Posted (Actual)
April 13, 2017
Study Record Updates
Last Update Posted (Actual)
April 13, 2017
Last Update Submitted That Met QC Criteria
April 7, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 605131
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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