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De Novo Lipogenesis of Sebaceous Glands in Acne

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02620813
Enrollment
32
Registered
2015-12-03
Start date
2015-10-31
Completion date
2017-10-12
Last updated
2021-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris

Keywords

acne, sebaceous gland, lipid, sebum

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.

Interventions

DRUGTretinoin

Subjects will apply 0.5% tretinoin cream nightly to their face for a total of 12 weeks.

DRUGIsotretinoin

Subjects will take isotretinoin as prescribed by their dermatologist.

Sponsors

University of California, Davis
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frame
Sebumeter measurement differences before and after treatment with isotretinoin3 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.3 months

Secondary

MeasureTime frame
Change in the lesion counts of inflammatory and non-inflammatory lesions.3 months
Change in the global acne grade score3 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).3 months
Difference in the fractional contribution of de novo lipogenesis (DNL) to the sebum total palmitate between those with and without acne3 months
Change in the investigator global assessment of acne3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026