De Novo Lipogenesis of Sebaceous Glands in Acne

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02620813
Recruitment Status : Recruiting
First Posted : December 3, 2015
Last Update Posted : June 29, 2018
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:

There are two purposes of this study:

  1. First, the investigators want to see what the differences are in de novo sebaceous lipid production of people with and without acne.
  2. Secondly, the investigators want to know what happens to sebaceous gland de novo lipid production before and after treatment with topical tretinoin and oral isotretinoin.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Tretinoin Drug: Isotretinoin Phase 4

Detailed Description:

The primary objective of this study is to understand how de novo lipid production of sebaceous glands are altered in acne and with acne directed therapy.

Hypothesis 1: The overall de novo lipogenesis will be increased in those with acne

Hypothesis 2: Treatment with topical tretinoin and systemic isotretinoin will reduce de novo lipogenesis.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : October 2015
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
No Intervention: No Acne
Healthy subjects without acne between the ages of 15-45
Experimental: Acne Subjects on Topical Tretinoin Treatment
Subjects with acne before and after topical retinoid therapy
Drug: Tretinoin
Subjects will apply 0.5% tretinoin cream nightly to their face for a total of 12 weeks.
Other Name: Retin-A

Experimental: Acne Subjects on Systemic Isotretinoin Treatment
Subjects with acne before and after isotretinoin therapy
Drug: Isotretinoin
Subjects will take isotretinoin as prescribed by their dermatologist.

Primary Outcome Measures :
  1. Sebumeter measurement differences before and after treatment with isotretinoin [ Time Frame: 3 months ]
  2. Change in the fractional contribution of DNL to the total sebum palmitate before and after treatment with isotretinoin at baseline and 3 months after treatment. [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Change in the global acne grade score [ Time Frame: 3 months ]
  2. Change in the investigator global assessment of acne [ Time Frame: 3 months ]
  3. Change in the lesion counts of inflammatory and non-inflammatory lesions. [ Time Frame: 3 months ]
  4. Difference in the fractional contribution of de novo lipogenesis (DNL) to the sebum total palmitate between those with and without acne [ Time Frame: 3 months ]
  5. Difference in the fractional contribution of DNL to the sebum total palmitate before and after treatment with a topical retinoid (adapalene, tazarotene, or tretinoin). [ Time Frame: 3 months ]

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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age 15 to 45 years of age
  • Subject/Parents/Legal Guardian be able to read and comprehend study procedure and consent forms
  • Have acne that is diagnosed by a board certified dermatologist
  • Meet one of the following criteria:

    • already been prescribed oral isotretinoin for treatment of acne
    • have already been prescribed a topical retinoid
    • eligible for prescription of topical tretinoin

Exclusion Criteria:

  • Those who have already initiated or completed a course of systemic isotretinoin
  • Those with seborrheic dermatitis, rosacea, or polycystic ovary syndrome
  • Those who are pregnant in female participants
  • 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 identifier (NCT number): NCT02620813

Contact: Raja K Sivamani, MD 9167035145
Contact: Negar Foolad, MAS

United States, California
Dermatology Research Area Recruiting
Davis, California, United States, 95616
Contact: Negar Foolad, MAS    916-734-1509   
Contact: Lauren A Hassoun, BS    916-734-6550   
Principal Investigator: Raja K Sivamani, MD         
UC Davis Department of Dermatology Recruiting
Sacramento, California, United States, 95816
Contact: Raja Sivamani, MD   
Sponsors and Collaborators
University of California, Davis


Responsible Party: University of California, Davis Identifier: NCT02620813     History of Changes
Other Study ID Numbers: 725019
First Posted: December 3, 2015    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: June 2018

Keywords provided by University of California, Davis:
sebaceous gland

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Dermatologic Agents
Antineoplastic Agents
Keratolytic Agents