Clinical trial NCT01764308: Effects of Omega-3 Fatty Acid Supplementation in Acne Patients
Official title: Omega-3 Fatty Acid Supplementation in Acne Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Acne
Keywords: acne; omega-3; isotretinoin; placebo
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2013-01-09
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Acne Lesion Count
timeFrame: up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Califonia, Los Angeles Division of Dermatology
state: California
Study officials:
affiliation: Kaiser Permanente
name: Christina N Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCLA Division of Dermatology
name: Carolyn Goh, MD
role: STUDY_CHAIR
References: