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
  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:


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 April 20, 2014