SmokingSebumNCT03112876
Sebum Collection and Skin Barrier Function Analysis
An observational study of Smoking and Acne, run by University of California, Davis at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking, Acne, Atopic Dermatitis
- What is being tested?
- Skin Surface Lipid Collection and Skin Barrier Function
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2014to 26 Feb 2016
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Subjects that are 12 years of age or older
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Department of Dermatology
Sacramento, California, 95816
About this study
Official title: 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
Read the 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.
- Conditions
- Smoking, Acne, Atopic Dermatitis, Aging
- Being tested
- Skin Surface Lipid Collection and Skin Barrier Function
- Keywords
- younger age, older age, atopic dermatitis, acne, smoker
- Medical subject headings
- Smoking, Acne Vulgaris, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin Surface Lipid Collection and Skin Barrier FunctionOther
Also called lipid profile, sebum secretion rate, skin water loss, skin hydration
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Skin Surface Lipid Collection and Skin Barrier Function | |
| 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. Receives: Other: Skin Surface Lipid Collection and Skin Barrier Function | |
| 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. Receives: Other: Skin Surface Lipid Collection and Skin Barrier Function | |
| 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. Receives: Other: Skin Surface Lipid Collection and Skin Barrier Function | |
| 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. Receives: Other: Skin Surface Lipid Collection and Skin Barrier Function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid Profile-aging
The lipid profile of the subject group will be evaluated through the use of painless tapes that will be applied to the skin.
Measured: 1 day
Lipid Profile-acne
The lipid profile of the subject group will be evaluated through the use of painless tapes that will be applied to the skin.
Measured: 1 day
Lipid Profile-atopic dermatitis
The lipid profile of the subject group will be evaluated through the use of painless tapes that will be applied to the skin.
Measured: 1 day
Lipid Profile-smoking
The lipid profile of the subject group will be evaluated through the use of painless tapes that will be applied to the skin.
Measured: 1 day
Secondary outcomes (4)
Skin Barrier Function- aging
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.
Measured: 1 day
Skin Barrier Function- acne
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.
Measured: 1 day
Skin Barrier Function- atopic dermatitis
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.
Measured: 1 day
Skin Barrier Function- smoking
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.
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 posted13 Apr 2017
- Study start27 Jun 2014
- Primary completion26 Feb 2016
- Study completion26 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raja K Sivamani, MD, Principal investigator, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03112876
- Sponsor's protocol ID
- 605131
- Acronym
- Sebum
- Status last verified
- Apr 2017
- First submitted
- 10 Jul 2014
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 21967555Sakai 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.
PubMed 16086742
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sebum Collection for Analysis and Correlation to Sebum Production, Barrier Function, and With Cutaneous and Internal Inflammatory Disease
- ClinicalTrials.gov ID
- NCT03112876
- Acronym / sponsor ID
- Sebum / 605131
- Conditions
- Smoking, Acne, Atopic Dermatitis, Aging
- Keywords
- younger age, older age, atopic dermatitis, acne, smoker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 27 Jun 2014 (actual)
- Primary completion
- 26 Feb 2016 (actual)
- Study completion
- 26 Feb 2016 (actual)
- First posted
- 13 Apr 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.
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
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Young Age - Healthy | – | Other: Skin Surface Lipid Collection and Skin Barrier FunctionThese 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. |
| Old Age -Healthy | – | Other: Skin Surface Lipid Collection and Skin Barrier FunctionThese 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. |
| Active Smoker | – | Other: Skin Surface Lipid Collection and Skin Barrier FunctionThese 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. |
| Dermatological skin condition: Acne vulgaris | – | Other: Skin Surface Lipid Collection and Skin Barrier FunctionThese 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. |
| Dermatological skin condition: Atopic dermatitis | – | Other: Skin Surface Lipid Collection and Skin Barrier FunctionThese 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Subjects that are 12 years of age or older
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin Surface Lipid Collection and Skin Barrier FunctionAlso: lipid profile, sebum secretion rate, skin water loss, skin hydrationAll 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 | Active Smoker, Dermatological skin condition: Acne vulgaris, Dermatological skin condition: Atopic dermatitis, Old Age -Healthy, Young Age - Healthy |
Primary outcome
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.
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.
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.
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.
4 secondary outcomes
Skin Barrier Function- aging
Time frame: 1 day
Skin Barrier Function- acne
Time frame: 1 day
Skin Barrier Function- atopic dermatitis
Time frame: 1 day
Skin Barrier Function- smoking
Time frame: 1 day
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 13 Apr 2017.
- Background: PubMed 21967555Ni 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.
- Background: PubMed 16086742Sakai 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.
- University of California-Davis Department of Dermatology Clinical ResearchLink provided by the sponsor.
Related trials for Smoking
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruiting
Flavored Electronic Nicotine Delivery Systems to Lower Smoking and Exposure to Tobacco Toxicants Among Cigarette Smokers Interested in Quitting, REFLECT Trial
Tobacco Cessation, Electronic Nicotine Delivery Systems
Not yet recruiting
Contingency Management to Promote Smoking Cessation Study
Smoking Cessation
Recruiting
Smoking Cessation in Patients With Cancer
Cancer, Tobacco Use
Not yet recruiting
Effectiveness Of Project EX: A Classroom-Based Smoking Prevention And Cessation Intervention Program
Focus of the Study is Smoking Cessation and Prevention, Smoking Prevention
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.
Raja K Sivamani, MD principal investigator
UC Davis
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 Smoking and Acne, run by University of California, Davis 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 1 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 13 Apr 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?
Lipid Profile-aging (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03112876, which also lists 2 linked publications.
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 13 Apr 2017.