Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01764308
Recruitment Status : Terminated (insufficient staff to complete recruitment)
First Posted : January 9, 2013
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Christina Kim, MD, Kaiser Permanente

Tracking Information
First Submitted Date  ICMJE January 7, 2013
First Posted Date  ICMJE January 9, 2013
Last Update Posted Date April 17, 2019
Study Start Date  ICMJE January 2013
Actual Primary Completion Date March 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01764308 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Omega-3 Fatty Acid Supplementation in Acne Patients
Official Title  ICMJE Omega-3 Fatty Acid Supplementation in Acne Patients
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acne
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 15, 2019)
31
Original Actual Enrollment  ICMJE
 (submitted: January 8, 2013)
90
Actual Study Completion Date  ICMJE March 31, 2019
Actual Primary Completion Date March 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01764308
Other Study ID Numbers  ICMJE O3FA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Christina Kim, MD, Kaiser Permanente
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christina N Kim, MD Kaiser Permanente
Study Chair: Carolyn Goh, MD UCLA Division of Dermatology
PRS Account University of California, Los Angeles
Verification Date April 2019

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