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Effects of Omega-3 Fatty Acid Supplementation in Acne Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Christina Kim, MD, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01764308
First received: January 7, 2013
Last updated: January 8, 2013
Last verified: January 2013
History of Changes
  Purpose

60 patients receiving isotretinoin and 90 subjects receiving oral antibiotic therapy 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Omega-3 Fatty Acid Supplementation in Acne Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Acne Lesion Count [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    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.


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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01764308

Locations
United States, California
University of Califonia, Los Angeles Division of Dermatology
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Christina N Kim, MD UCLA Division of Dermatology
  More Information

No publications provided

Responsible Party: Christina Kim, MD, Assistant Clinical Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01764308     History of Changes
Other Study ID Numbers: O3FA
Study First Received: January 7, 2013
Last Updated: January 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
acne; omega-3; isotretinoin; placebo

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases

ClinicalTrials.gov processed this record on May 23, 2013