De Novo Lipogenesis of Sebaceous Glands in Acne

Study Overview
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Brief Summary
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There are two purposes of this study: First, the investigators want to see what the differences are in de novo sebaceous lipid production of people with and without acne. 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
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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.

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Tretinoin
* Drug: Isotretinoin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Acne<br>Healthy subjects without acne between the ages of 15-45 | |
| Experimental: Acne Subjects on Topical Tretinoin Treatment<br>Subjects with acne before and after topical retinoid therapy | Drug: Tretinoin<br>* Subjects will apply 0.5% tretinoin cream nightly to their face for a total of 12 weeks.<br>* Other names: Retin-A;|
| Experimental: Acne Subjects on Systemic Isotretinoin Treatment<br>Subjects with acne before and after isotretinoin therapy | Drug: Isotretinoin<br>* Subjects will take isotretinoin as prescribed by their dermatologist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acne, lipid, sebaceous gland, sebum