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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.
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:
Exclusion Criteria:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| O3FA | Experimental | Omega 3 Fatty Acid 1200mg twice a day for 24 weeks |
|
| Placebo | Placebo Comparator | 4 tablets twice a day for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 | Dietary Supplement | 1200mg twice a day for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina N Kim, MD | Kaiser Permanente | Principal Investigator |
| Carolyn Goh, MD | UCLA Division of Dermatology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Califonia, Los Angeles Division of Dermatology | Los Angeles | California | 90095 | United States |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| D015525 | Fatty Acids, Omega-3 |
| D017962 | alpha-Linolenic Acid |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| Placebo | Dietary Supplement | 4 tablets twice a day for 24 weeks |
|
|
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D008042 | Linolenic Acids |
| D005228 | Fatty Acids, Essential |
| D002241 | Carbohydrates |