Effects of Omega-3 Fatty Acid Supplementation in Acne Patients (Omega-3)

April 15, 2019 updated by: Christina Kim, MD, University of California, Los Angeles

Omega-3 Fatty Acid Supplementation in Acne Patients

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • University of Califonia, Los Angeles Division of Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acne Lesion Count
Time Frame: up to 24 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Investigators

  • Principal Investigator: Christina N Kim, MD, Kaiser Permanente
  • Study Chair: Carolyn Goh, MD, UCLA Division of Dermatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

March 31, 2019

Study Completion (Actual)

March 31, 2019

Study Registration Dates

First Submitted

January 7, 2013

First Submitted That Met QC Criteria

January 8, 2013

First Posted (Estimate)

January 9, 2013

Study Record Updates

Last Update Posted (Actual)

April 17, 2019

Last Update Submitted That Met QC Criteria

April 15, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • O3FA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acne

Clinical Trials on Omega-3

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe