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

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ClinicalTrials.gov Identifier: NCT01764308
Recruitment Status : Recruiting
First Posted : January 9, 2013
Last Update Posted : October 28, 2016
Sponsor:
Information provided by (Responsible Party):
Christina Kim, MD, Kaiser Permanente

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acne Dietary Supplement: Omega-3 Dietary Supplement: Placebo Phase 3

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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  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Omega-3 Fatty Acid Supplementation in Acne Patients
Study Start Date : January 2013
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
U.S. FDA Resources

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 Name: Omega-3 fatty acid; fish oil supplement; alpha-linolenic acid
Dietary Supplement: Placebo
4 tablets twice a day for 24 weeks
Other Name: 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 Name: Omega-3 fatty acid; fish oil supplement; alpha-linolenic acid
Dietary Supplement: Placebo
4 tablets twice a day for 24 weeks
Other Name: Sugar pill



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01764308


Contacts
Contact: Gail D Thames, BA 310-825-0453 gthames@mednet.ucla.edu

Locations
United States, California
University of Califonia, Los Angeles Division of Dermatology Recruiting
Los Angeles, California, United States, 90095
Contact: Gail D Thames, BA    310-825-0453    gthames@mednet.ucla.edu   
Principal Investigator: Christina N Kim, MD         
Sub-Investigator: Jenny E Kim, MD, PhD         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Christina N Kim, MD Kaiser Permanente
Study Chair: Carolyn Goh, MD UCLA Division of Dermatology

Responsible Party: Christina Kim, MD, Physician, Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01764308     History of Changes
Other Study ID Numbers: O3FA
First Posted: January 9, 2013    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Christina Kim, MD, Kaiser Permanente:
acne; omega-3; isotretinoin; placebo