Effects of Omega-3 Fatty Acid Supplementation in Acne Patients

Study Overview
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Brief Summary
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60 patients receiving isotretinoin will be recruited from the UCLA acne specialty clinic. Subjects will be randomized in a 1:1 ratio to receive placebo or omega-3 1200mg twice a day for 24 weeks.

Detailed Description
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Experimental Design 60 patients receiving isotretinoin will be recruited from the UCLA acne specialty clinic. Subjects will be randomized in a 1:1 ratio to receive placebo or omega-3 1200mg twice a day for 24 weeks. Inclusion Criteria: Male or female above 18 years of age. Moderate to severe disease at the baseline of the study identified by their dermatologist. Will start treatment with systemic therapy for acne in the form of either isotretinoin or oral antibiotics. Patients able and willing to comply with the procedures in the study protocol. Exclusion Criteria: Patients with history of taking omega-3 supplements for high triglyceride levels. Patients taking medications for dyslipidemia, blood thinners, or high blood pressure medication. Patients with a history of adverse reaction to omega-3 fatty acid supplementation. Unwilling to give inform consent First Visit (Baseline) All patients will complete an intake survey. This survey will include self-assessment via Leed's standardized photo scale, and the Skindex 16 quality of life questionnaire. Physicians will complete acne assessment on all patients. This includes lesion counts, standardized Leed's photo scale and global assessment scale 0-5. Fasting blood sample will be obtained for chemistry and lipid panel if being treated with isotretinoin, as is standard for this therapy. Follow-up visits at weeks 8, 16, 24: Patients will come in at weeks 8, 16 and 24 for the following procedures: All patients will fill out follow-up survey at each visit. The survey will elicit information regarding compliance with medication, compliance with supplementation, side effects of supplementation, side effects of acne therapy, and satisfaction with therapy. Follow-up surveys will include patient self assessment with Leed's photo scale, and Skindex 16 questionnaire. Physicians will complete acne assessment on all patients. This includes lesion counts, photo scale and global assessment (Grade 0-5). See attached Physician checklist. Patients will have fasting blood drawn for lipid panel if being treated with isotretinoin, as is standard for this therapy. Data analysis: In all study patients being treated for acne, lesion counts will be assessed and evaluated for any differences between patients on omega-3 fatty acid supplementation and not on supplementation. Global assessment, photo scale assessment and Skindex-16 quality of life assessment will be compared between patients with and without supplementation. We will compare triglyceride levels in patients being treated with isotretinoin with and without omega-3 fatty acid supplementation. Overall satisfaction with therapy will be compared between patients with O3FA supplementation and without supplementation.

Official Title
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Omega-3 Fatty Acid Supplementation in Acne Patients

Conditions
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Acne

Intervention / Treatment
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* Dietary Supplement: Omega-3
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female above 18 years of age. Moderate to severe disease at the baseline of the study identified by their dermatologist. Will start treatment with systemic therapy for acne in the form of either isotretinoin or oral antibiotics. Patients able and willing to comply with the procedures in the study protocol. Exclusion Criteria: Patients with history of taking omega-3 supplements for high triglyceride levels. Patients taking medications for dyslipidemia, blood thinners, or high blood pressure medication. Patients with a history of adverse reaction to omega-3 fatty acid supplementation. Unwilling to give inform consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: O3FA<br>Omega 3 Fatty Acid 1200mg twice a day for 24 weeks | Dietary Supplement: Omega-3<br>* 1200mg twice a day for 24 weeks<br>* Other names: Omega-3 fatty acid; fish oil supplement; alpha-linolenic acid;Dietary Supplement: Placebo<br>* 4 tablets twice a day for 24 weeks<br>* Other names: Sugar pill;|
| Placebo Comparator: Placebo<br>4 tablets twice a day for 24 weeks | Dietary Supplement: Omega-3<br>* 1200mg twice a day for 24 weeks<br>* Other names: Omega-3 fatty acid; fish oil supplement; alpha-linolenic acid;Dietary Supplement: Placebo<br>* 4 tablets twice a day for 24 weeks<br>* Other names: Sugar pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acne Lesion Count | In all study patients being treated for acne, lesion counts will be assessed and evaluated for any differences between patients on omega-3 fatty acid supplementation and not on supplementation. | up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acne; omega-3; isotretinoin; placebo