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临床试验/NCT01764308
NCT01764308终止3 期

Omega-3 Fatty Acid Supplementation in Acne Patients

University of California, Los Angeles2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2013年1月最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
终止
入组人数
31
试验地点
2
主要终点
Acne Lesion Count

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

O3FA

Experimental

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

干预措施: Placebo (Dietary Supplement)

Placebo

Placebo Comparator

4 tablets twice a day for 24 weeks

干预措施: Placebo (Dietary Supplement)

O3FA

Experimental

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

干预措施: Omega-3 (Dietary Supplement)

Placebo

Placebo Comparator

4 tablets twice a day for 24 weeks

干预措施: Omega-3 (Dietary Supplement)

结局指标

主要结局

Acne Lesion Count

时间窗: up to 24 weeks

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christina Kim, MD

Physician

Kaiser Permanente

研究点 (2)

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