Effects of Omega-3 Fatty Acid Supplementation in Acne Patients (Omega-3)
Primary Purpose
Acne
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Omega-3
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acne focused on measuring acne; omega-3; isotretinoin; placebo
Eligibility 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
Sites / Locations
- University of Califonia, Los Angeles Division of Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
O3FA
Placebo
Arm Description
Omega 3 Fatty Acid 1200mg twice a day for 24 weeks
4 tablets twice a day for 24 weeks
Outcomes
Primary Outcome Measures
Acne Lesion Count
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01764308
First Posted
January 7, 2013
Last Updated
April 15, 2019
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT01764308
Brief Title
Effects of Omega-3 Fatty Acid Supplementation in Acne Patients
Acronym
Omega-3
Official Title
Omega-3 Fatty Acid Supplementation in Acne Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
insufficient staff to complete recruitment
Study Start Date
January 2013 (undefined)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
March 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne
Keywords
acne; omega-3; isotretinoin; placebo
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
O3FA
Arm Type
Experimental
Arm Description
Omega 3 Fatty Acid 1200mg twice a day for 24 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
4 tablets twice a day for 24 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3
Other Intervention Name(s)
Omega-3 fatty acid; fish oil supplement; alpha-linolenic acid
Intervention Description
1200mg twice a day for 24 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill
Intervention Description
4 tablets twice a day for 24 weeks
Primary Outcome Measure Information:
Title
Acne Lesion Count
Description
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.
Time Frame
up to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina N Kim, MD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carolyn Goh, MD
Organizational Affiliation
UCLA Division of Dermatology
Official's Role
Study Chair
Facility Information:
Facility Name
University of Califonia, Los Angeles Division of Dermatology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effects of Omega-3 Fatty Acid Supplementation in Acne Patients
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