De Novo Lipogenesis of Sebaceous Glands in Acne

August 4, 2021 updated by: University of California, Davis

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

32

Phase

  • Early Phase 1

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

    • California
      • Davis, California, United States, 95616
        • Dermatology Research Area
      • 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

Ages Eligible for Study

15 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
Subjects will apply 0.5% tretinoin cream nightly to their face for a total of 12 weeks.
Other Names:
  • Retin-A
Experimental: Acne Subjects on Systemic Isotretinoin Treatment
Subjects with acne before and after isotretinoin therapy
Subjects will take isotretinoin as prescribed by their dermatologist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sebumeter measurement differences before and after treatment with isotretinoin
Time Frame: 3 months
3 months
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
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in the global acne grade score
Time Frame: 3 months
3 months
Change in the investigator global assessment of acne
Time Frame: 3 months
3 months
Change in the lesion counts of inflammatory and non-inflammatory lesions.
Time Frame: 3 months
3 months
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
3 months
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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

October 1, 2015

Primary Completion (Actual)

October 12, 2017

Study Completion (Actual)

October 12, 2017

Study Registration Dates

First Submitted

December 1, 2015

First Submitted That Met QC Criteria

December 2, 2015

First Posted (Estimate)

December 3, 2015

Study Record Updates

Last Update Posted (Actual)

August 5, 2021

Last Update Submitted That Met QC Criteria

August 4, 2021

Last Verified

August 1, 2021

More Information

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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