De Novo Lipogenesis of Sebaceous Glands in Acne

NCT02620813 | Completed Early Phase 1

• 1 other identifier: 725019
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

There are two purposes of this study:

1. 1.First, the investigators want to see what the differences are in de novo sebaceous lipid production of people with and without acne.
2. 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.

Conditions

Acne Vulgaris

Keywords

acne; sebaceous gland; lipid; sebum

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Change in the global acne grade score

  3 months

• Change in the investigator global assessment of acne

  3 months

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

  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

• 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

Study Arms (3)

No Acne

NO INTERVENTION

Healthy subjects without acne between the ages of 15-45

Acne Subjects on Topical Tretinoin Treatment

EXPERIMENTAL

Subjects with acne before and after topical retinoid therapy

Drug: Tretinoin

Acne Subjects on Systemic Isotretinoin Treatment

EXPERIMENTAL

Subjects with acne before and after isotretinoin therapy

Drug: Isotretinoin

Interventions

Tretinoin DRUG

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

Also known as: Retin-A

Acne Subjects on Topical Tretinoin Treatment

Isotretinoin DRUG

Subjects will take isotretinoin as prescribed by their dermatologist.

Acne Subjects on Systemic Isotretinoin Treatment

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (2)

Dermatology Research Area

Davis, California, 95616, United States

Location

UC Davis Department of Dermatology

Sacramento, California, 95816, United States

Location

Related Publications (21)

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MeSH Terms

Conditions

Acne Vulgaris

Interventions

Tretinoin; Isotretinoin

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Vitamin A; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: December 3, 2015
• Study Start: October 1, 2015
• Primary Completion: October 12, 2017
• Study Completion: October 12, 2017
• Last Updated: August 5, 2021

Record last verified: 2021-08

Locations

US (2)