Clinical trial NCT02620813: De Novo Lipogenesis of Sebaceous Glands in Acne
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Acne Vulgaris
Keywords: acne
sebaceous gland
lipid
sebum
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2015-12-03
Enrollment: 32
Sex: ALL
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

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

Primary outcomes:
measure: Sebumeter measurement differences before and after treatment with isotretinoin
timeFrame: 3 months
measure: 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.
timeFrame: 3 months
Secondary outcomes:
measure: Change in the global acne grade score
timeFrame: 3 months
measure: Change in the investigator global assessment of acne
timeFrame: 3 months
measure: Change in the lesion counts of inflammatory and non-inflammatory lesions.
timeFrame: 3 months
measure: Difference in the fractional contribution of de novo lipogenesis (DNL) to the sebum total palmitate between those with and without acne
timeFrame: 3 months
measure: Difference in the fractional contribution of DNL to the sebum total palmitate before and after treatment with a topical retinoid (adapalene, tazarotene, or tretinoin).
timeFrame: 3 months
Other outcomes:
Locations:
city: Davis
country: United States
facility: Dermatology Research Area
state: California
city: Sacramento
country: United States
facility: UC Davis Department of Dermatology
state: California
Study officials:
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