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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01764308
Other study ID # O3FA
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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