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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):

January 7, 2013
January 9, 2013
October 28, 2016
January 2013
January 2019   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01764308 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effects of Omega-3 Fatty Acid Supplementation in Acne Patients
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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Acne
  • 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
  • Experimental: O3FA
    Omega 3 Fatty Acid 1200mg twice a day for 24 weeks
    Interventions:
    • Dietary Supplement: Omega-3
    • Dietary Supplement: Placebo
  • Placebo Comparator: Placebo
    4 tablets twice a day for 24 weeks
    Interventions:
    • Dietary Supplement: Omega-3
    • Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
January 2020
January 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Yes
Contact: Gail D Thames, BA 310-825-0453 gthames@mednet.ucla.edu
United States
 
 
NCT01764308
O3FA
No
Not Provided
Plan to Share IPD: Undecided
Christina Kim, MD, Kaiser Permanente
University of California, Los Angeles
Not Provided
Principal Investigator: Christina N Kim, MD Kaiser Permanente
Study Chair: Carolyn Goh, MD UCLA Division of Dermatology
University of California, Los Angeles
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP