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:

  1. Young vs older healthy population
  2. Atopic dermatitis vs Acne vs Healthy controls
  3. Active smokers vs non-smoker controls

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Skin Surface Lipid Collection and Skin Barrier Function
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:
  • lipid profile
  • sebum secretion rate
  • skin water loss
  • skin hydration
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.
Other: Skin Surface Lipid Collection and Skin Barrier Function
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:
  • lipid profile
  • sebum secretion rate
  • skin water loss
  • skin hydration
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.
Other: Skin Surface Lipid Collection and Skin Barrier Function
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:
  • lipid profile
  • sebum secretion rate
  • skin water loss
  • skin hydration
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.
Other: Skin Surface Lipid Collection and Skin Barrier Function
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:
  • lipid profile
  • sebum secretion rate
  • skin water loss
  • skin hydration
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.
Other: Skin Surface Lipid Collection and Skin Barrier Function
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:
  • lipid profile
  • sebum secretion rate
  • skin water loss
  • skin hydration

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Davis

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

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 27, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 26, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 26, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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