De Novo Lipogenesis of Sebaceous Glands in Acne

Early Phase 1

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Isotretinoin; Drug: Tretinoin

• Registration Number: NCT02620813
• Lead Sponsor: University of California, Davis

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-12-01
• Study First Submitted QC: 2015-12-02
• Study First Posted: 2015-12-03
• Primary Completion: 2017-10-12
• Study Completion: 2017-10-12
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-04
• Last Update Posted: 2021-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acne Subjects on Systemic Isotretinoin Treatment	Isotretinoin	Subjects with acne before and after isotretinoin therapy
Acne Subjects on Topical Tretinoin Treatment	Tretinoin	Subjects with acne before and after topical retinoid therapy

Primary Outcome Measures

Name	Time	Method
Sebumeter measurement differences before and after treatment with isotretinoin	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.	3 months

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Dermatology Research Area; 🇺🇸 Davis, California, United States

UC Davis Department of Dermatology; 🇺🇸 Sacramento, California, United States