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De Novo Lipogenesis of Sebaceous Glands in Acne

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tretinoin
Isotretinoin
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Acne Vulgaris focused on measuring acne, sebaceous gland, lipid, sebum

Eligibility Criteria

15 Years - 45 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dermatology Research Area
  • UC Davis Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

No Acne

Acne Subjects on Topical Tretinoin Treatment

Acne Subjects on Systemic Isotretinoin Treatment

Arm Description

Healthy subjects without acne between the ages of 15-45

Subjects with acne before and after topical retinoid therapy

Subjects with acne before and after isotretinoin therapy

Outcomes

Primary Outcome Measures

Sebumeter measurement differences before and after treatment with isotretinoin
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.

Secondary Outcome Measures

Change in the global acne grade score
Change in the investigator global assessment of acne
Change in the lesion counts of inflammatory and non-inflammatory lesions.
Difference in the fractional contribution of de novo lipogenesis (DNL) to the sebum total palmitate between those with and without acne
Difference in the fractional contribution of DNL to the sebum total palmitate before and after treatment with a topical retinoid (adapalene, tazarotene, or tretinoin).

Full Information

First Posted
December 1, 2015
Last Updated
August 4, 2021
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT02620813
Brief Title
De Novo Lipogenesis of Sebaceous Glands in Acne
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 12, 2017 (Actual)
Study Completion Date
October 12, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

5. Study Description

Brief Summary
There are two purposes of this study: First, the investigators want to see what the differences are in de novo sebaceous lipid production of people with and without acne. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
acne, sebaceous gland, lipid, sebum

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Acne
Arm Type
No Intervention
Arm Description
Healthy subjects without acne between the ages of 15-45
Arm Title
Acne Subjects on Topical Tretinoin Treatment
Arm Type
Experimental
Arm Description
Subjects with acne before and after topical retinoid therapy
Arm Title
Acne Subjects on Systemic Isotretinoin Treatment
Arm Type
Experimental
Arm Description
Subjects with acne before and after isotretinoin therapy
Intervention Type
Drug
Intervention Name(s)
Tretinoin
Other Intervention Name(s)
Retin-A
Intervention Description
Subjects will apply 0.5% tretinoin cream nightly to their face for a total of 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Isotretinoin
Intervention Description
Subjects will take isotretinoin as prescribed by their dermatologist.
Primary Outcome Measure Information:
Title
Sebumeter measurement differences before and after treatment with isotretinoin
Time Frame
3 months
Title
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 Measure Information:
Title
Change in the global acne grade score
Time Frame
3 months
Title
Change in the investigator global assessment of acne
Time Frame
3 months
Title
Change in the lesion counts of inflammatory and non-inflammatory lesions.
Time Frame
3 months
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Dermatology Research Area
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States
Facility Name
UC Davis Department of Dermatology
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States

12. IPD Sharing Statement

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De Novo Lipogenesis of Sebaceous Glands in Acne

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