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Completed

NCT Number: NCT02620813

De Novo Lipogenesis of Sebaceous Glands in Acne

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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

15 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Dermatology Research Area, Davis, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tretinoin

Drug

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

Other names: Retin-A

isotretinoin

Drug

Subjects will take isotretinoin as prescribed by their dermatologist.

Primary outcomes

  1. Sebumeter measurement differences before and after treatment with isotretinoin

    Time frame: 3 months

  2. 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

  1. Change in the global acne grade score

    Time frame: 3 months

  2. Change in the investigator global assessment of acne

    Time frame: 3 months

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

    Time frame: 3 months

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 3, 2015
Registry last updated
Aug 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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