Effects of Omega-3 Fatty Acid Supplementation in Acne Patients

NCT ID: NCT01764308

Last Updated: 2019-04-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2019-03-31

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.

Conditions

Acne

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

O3FA

Omega 3 Fatty Acid 1200mg twice a day for 24 weeks

Group Type: EXPERIMENTAL

Omega-3

Intervention Type: DIETARY_SUPPLEMENT

1200mg twice a day for 24 weeks

Placebo

Intervention Type: DIETARY_SUPPLEMENT

4 tablets twice a day for 24 weeks

Placebo

4 tablets twice a day for 24 weeks

Group Type: PLACEBO_COMPARATOR

Omega-3

Intervention Type: DIETARY_SUPPLEMENT

1200mg twice a day for 24 weeks

Placebo

Intervention Type: DIETARY_SUPPLEMENT

4 tablets twice a day for 24 weeks

Interventions

Omega-3

1200mg twice a day for 24 weeks

Intervention Type: DIETARY_SUPPLEMENT

Placebo

4 tablets twice a day for 24 weeks

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Omega-3 fatty acid; fish oil supplement; alpha-linolenic acid; Sugar pill

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Christina Kim, MD

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christina N Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Carolyn Goh, MD

Role: STUDY_CHAIR

UCLA Division of Dermatology

Locations

University of Califonia, Los Angeles Division of Dermatology

Los Angeles, California, United States

Countries

United States

Other Identifiers

O3FA

Identifier Type: -

Identifier Source: org_study_id