De Novo Lipogenesis of Sebaceous Glands in Acne

University of California (UC) Davis

Status and phase: Completed; Early Phase 1

Conditions: Acne Vulgaris

Treatments: Drug: Isotretinoin; Drug: Tretinoin

Study type: Interventional

Funder types: Other

Identifiers

NCT02620813

725019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 15 to 45 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 3 patient groups

No Acne

No Intervention group

Description:

Healthy subjects without acne between the ages of 15-45

Acne Subjects on Topical Tretinoin Treatment

Experimental group

Description:

Subjects with acne before and after topical retinoid therapy

Treatment:

Drug: Tretinoin

Acne Subjects on Systemic Isotretinoin Treatment

Experimental group

Description:

Subjects with acne before and after isotretinoin therapy

Treatment:

Drug: Isotretinoin