Effects of Omega-3 Fatty Acid Supplementation in Acne Patients
Status: | Recruiting |
---|---|
Conditions: | Acne, Acne |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 5/11/2018 |
Start Date: | January 2013 |
End Date: | January 2020 |
Contact: | Gail D Thames, BA |
Email: | gthames@mednet.ucla.edu |
Phone: | 310-825-0453 |
Omega-3 Fatty Acid Supplementation in Acne Patients
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.
Subjects will be randomized in a 1:1 ratio to receive placebo or omega-3 1200mg twice a day
for 24 weeks.
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.
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.
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
We found this trial at
1
site
Los Angeles, California 90095
Principal Investigator: Christina N Kim, MD
Phone: 310-825-0453
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