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

This study is currently recruiting participants.
Verified October 2016 by Christina Kim, MD, Kaiser Permanente
Sponsor:
ClinicalTrials.gov Identifier:
NCT01764308
First Posted: January 9, 2013
Last Update Posted: October 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Christina Kim, MD, Kaiser Permanente
  Purpose
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 Intervention Phase
Acne Dietary Supplement: Omega-3 Dietary Supplement: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Omega-3 Fatty Acid Supplementation in Acne Patients

Resource links provided by NLM:


Further study details as provided by Christina Kim, MD, Kaiser Permanente:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 90
Study Start Date: January 2013
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Responsible Party: Christina Kim, MD, Physician, Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01764308     History of Changes
Other Study ID Numbers: O3FA
First Submitted: January 7, 2013
First Posted: January 9, 2013
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