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The Lipid Profile of the Skin Surface in Acne (Acne)

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ClinicalTrials.gov Identifier: NCT02180425
Recruitment Status : Completed
First Posted : July 2, 2014
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
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.

Condition or disease Intervention/treatment
Acne Drug: Tretinoin or Adapalene Drug: Isotretinoin

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.

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Lipid Profile of the Skin Surface in Acne
Study Start Date : November 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Group/Cohort Intervention/treatment
Healthy Group
The subjects in this group do not have a history of acne.
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.
Drug: Tretinoin or Adapalene
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 Name: Retin A

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.
Drug: Isotretinoin
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 Name: Accutane




Primary Outcome Measures :
  1. Skin lipid profile of acne and healthy patients [ Time Frame: baseline visit ]
    Compare the skin lipid profile of acne and healthy patients at baseline


Secondary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples Without DNA
Sebum collections from sebutapes


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02180425


Locations
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United States, California
Dermatology Research Area
Davis, California, United States, 95616
UC Davis Department of Dermatology
Sacramento, California, United States, 95816
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Raja K Sivamani, MD UC Davis

Additional Information:
Publications:
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02180425     History of Changes
Other Study ID Numbers: 531506
First Posted: July 2, 2014    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Keywords provided by University of California, Davis:
acne
lipid
tretinoin
isotretinoin
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Adapalene
Tretinoin
Isotretinoin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Antineoplastic Agents
Keratolytic Agents