- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02180425
The Lipid Profile of the Skin Surface in Acne (Acne)
May 25, 2017 updated by: University of California, Davis
The purpose of this study is to evaluate the differences in the skin lipid profile of patients with and without acne.
Secondly, the goal is to learn more about what the effects of retinoinds (topical and systemic) are on the the skin lipid profile.
We hypothesize that the skin lipid profile of subjects with acne will be lower in inflammatory lipids in comparison to subjects without acne.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Skin lipid profile will be conducted via sebutapes- adhesive tapes that painlessly absorbs sebum from the face.
These tapes will be placed on the face for 1 hour.
A photograph of the face will be taken during each study visit.
A sebumeter will also be used to measure skin sebum secretion rate.
Study Type
Observational
Enrollment (Actual)
30
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
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California
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Davis, California, United States, 95616
- Dermatology Research Area
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Sacramento, California, United States, 95816
- UC Davis Department of Dermatology
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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 to 30 years (ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects will be from the UC Davis Dermatology Clinic, surrounding dermatology clinics, from the UC Davis undergraduate campus, and from the California State University Sacramento campus.
Description
Inclusion Criteria:
- age 12 to 30 years
- have been prescribed tretinoin OR isotretinoin
Exclusion Criteria:
- those who have taken isotretinoin (systemic)
- those who used tretinoin or other topical retinoid within two weeks of starting the study
- those with seborrheic dermatitis, rosacea, or polycystic ovary syndrome
- those who are pregnant, prisoners, or cognitively impaired
- those who do not fit the inclusion criteria
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 |
|---|---|
|
Healthy Group
The subjects in this group do not have a history of acne.
|
|
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Acne Group, Topical Retinoid
These subjects have been prescribed a topical retinoid for their acne.
They will participate in the study for a period of 1 month.
|
Subjects will apply a pea sized amount of topical retinoid cream once daily at night for 30 days.
Subjects will return for a follow-up visit.
Other Names:
|
|
Acne Group, Isotretinoin
These subjects have been prescribed isotretinoin for their acne.
They will participate in the study for a period of 5-6 months.
|
Subjects will take one pill once daily for 5 months.
Subjects will return after 1 month and after 4-5 months of treatment for skin lipid profiling.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Skin lipid profile of acne and healthy patients
Time Frame: baseline visit
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Compare the skin lipid profile of acne and healthy patients at baseline
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baseline visit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Skin lipid profile of acne patients after treatment
Time Frame: at 1 month and 4-5 months of treatment
|
Patients in the topical retinoid group will have their lipids evaluated after 1 month of treatment.
Patients in the systemic retinoid (isotretinoin) group will have their lipids evaluated after 1 and 4-5 months of treatment.
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at 1 month and 4-5 months of treatment
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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
- Doshi A, Zaheer A, Stiller MJ. A comparison of current acne grading systems and proposal of a novel system. Int J Dermatol. 1997 Jun;36(6):416-8. doi: 10.1046/j.1365-4362.1997.00099.x. No abstract available.
- Blume U, Verschoore M, Poncet M, Czernielewski J, Orfanos CE, Schaefer H. The vellus hair follicle in acne: hair growth and sebum excretion. Br J Dermatol. 1993 Jul;129(1):23-7. doi: 10.1111/j.1365-2133.1993.tb03306.x.
- Zouboulis CC, Baron JM, Bohm M, Kippenberger S, Kurzen H, Reichrath J, Thielitz A. Frontiers in sebaceous gland biology and pathology. Exp Dermatol. 2008 Jun;17(6):542-51. doi: 10.1111/j.1600-0625.2008.00725.x.
- Thody AJ, Shuster S. Control and function of sebaceous glands. Physiol Rev. 1989 Apr;69(2):383-416. doi: 10.1152/physrev.1989.69.2.383.
- Morello AM, Downing DT, Strauss JS. Octadecadienoic acids in the skin surface lipids of acne patients and normal subjects. J Invest Dermatol. 1976 May;66(5):319-23. doi: 10.1111/1523-1747.ep12482300.
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
November 1, 2013
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
June 30, 2014
First Submitted That Met QC Criteria
June 30, 2014
First Posted (Estimate)
July 2, 2014
Study Record Updates
Last Update Posted (Actual)
May 30, 2017
Last Update Submitted That Met QC Criteria
May 25, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Acneiform Eruptions
- Sebaceous Gland Diseases
- Acne Vulgaris
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Dermatologic Agents
- Keratolytic Agents
- Tretinoin
- Isotretinoin
- Adapalene
Other Study ID Numbers
- 531506
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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