Effects of Omega-3 Fatty Acid Supplementation in Acne Patients

NCT01764308 | Terminated Phase 3

• 1 other identifier: O3FA
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne

Keywords

acne; omega-3; isotretinoin; placebo

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

O3FA

EXPERIMENTAL

Omega 3 Fatty Acid 1200mg twice a day for 24 weeks

Dietary Supplement: Omega-3; Dietary Supplement: Placebo

Placebo

PLACEBO COMPARATOR

4 tablets twice a day for 24 weeks

Dietary Supplement: Omega-3; Dietary Supplement: Placebo

Interventions

Omega-3 DIETARY_SUPPLEMENT

1200mg twice a day for 24 weeks

Also known as: Omega-3 fatty acid; fish oil supplement; alpha-linolenic acid

O3FA; Placebo

Placebo DIETARY_SUPPLEMENT

4 tablets twice a day for 24 weeks

Also known as: Sugar pill

O3FA; Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of Califonia, Los Angeles Division of Dermatology

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Docosahexaenoic Acids; Fatty Acids, Omega-3; alpha-Linolenic Acid; Sugars

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Linolenic Acids; Fatty Acids, Essential; Carbohydrates

Study Officials

• Christina N Kim, MD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

• Carolyn Goh, MD

  UCLA Division of Dermatology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: January 7, 2013
• First Posted: January 9, 2013
• Study Start: January 1, 2013
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: April 17, 2019

Record last verified: 2019-04

Locations

US (1)