Effects of Omega-3 Fatty Acid Supplementation in Acne Patients

Acne Clinical Trial

— Omega-3  

Official title:

Omega-3 Fatty Acid Supplementation in Acne Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01764308
• Other study ID #: O3FA
• Status: Terminated
• Phase: Phase 3
• Start date: January 2013
• Est. completion date: March 31, 2019

Study information

• Verified date: April 2019
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne

Intervention

Dietary Supplement:
• Omega-3
1200mg twice a day for 24 weeks
• Placebo
4 tablets twice a day for 24 weeks

Locations

Country	Name	City	State
United States	University of Califonia, Los Angeles Division of Dermatology	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 24 weeks