De Novo Lipogenesis of Sebaceous Glands in Acne

Early Phase 1CompletedNCT02620813

University of California, Davis32 enrolled

Overview

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.

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

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Acne Vulgaris

Interventions

TretinoinDRUG

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

IsotretinoinDRUG

Subjects will take isotretinoin as prescribed by their dermatologist.

Eligibility

Sex: ALLMin age: 15 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Dermatology Research Area

Davis, California, United States

UC Davis Department of Dermatology

Sacramento, California, United States

Outcomes

Primary Outcomes

Sebumeter measurement differences before and after treatment with isotretinoin

Time frame: 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

Secondary Outcomes

Change in the global acne grade score

Time frame: 3 months

Change in the investigator global assessment of acne

Time frame: 3 months

Change in the lesion counts of inflammatory and non-inflammatory lesions.

Time frame: 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

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

Data from ClinicalTrials.gov

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