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Impact of a Daily Application of an Omega-3 Monoglycerides Based Serum and Cream on the Skin Microbiota (COS-PBP-03)

2026年5月6日 更新者:SCF Pharma

Impact of a Daily Application of an Omega-3 Monoglycerides Based Serum and Cream on the Ratio of 4 Bacteria of the Skin Microbiota (Staphylococcus Aureus, Staphylococcus Epidermis, Cutibacterium Acnes and Streptococcus Pyogenes). Exploratory Study (COS-PBP-03).

This exploratory study aims to investigate the prebiotic potential of daily application of an omega-3 serum and cream to skin affected by eczema. The study will also collect data on any potential adverse effects of the products. Ten subjects will be enrolled in the study and will receive the same treatment for fourteen days. Their baseline condition before treatment will serve as a control for the effects observed after treatment on the targeted eczema area. A second area of eczema treated with the patient's usual skincare routine will also serve as a control.

研究概览

地位

尚未招聘

条件

详细说明

Omega-3 fatty acids, and Eicosapentaenoic acid (EPA) in particular, are known to promote the resolution of inflammation, unlike omega-6 fatty acids, which are pro-inflammatory. The skin, the largest organ in the human body, receives a high proportion of omega-6 fatty acids because skincare products are primarily composed of vegetable oils rich in omega-6. This imbalance could be one of the causes of inflammatory skin conditions such as eczema. Conventional omega-3s must pass through the digestive tract to be activated as monoglycerides. Therefore, their use in topical formulations is not practical. However, the recent development of pre-activated omega-3 monoglycerides finally opens the possibility of introducing active omega-3 fatty acids into moisturizing products.

All subjects will receive the same treatment for a similar duration. A skin area with eczema lesions will be identified during the screening visit. Subjects will be asked to apply the serum and cream to the clean, targeted area at least once daily for fourteen (14) days. The baseline condition before treatment will serve as a control for the effects observed after treatment on the targeted area. A second eczema area treated with the patient's usual care will also serve as a control.

Both targeted eczema areas will be used to measure the main study parameters:

  1. Quantify, by quantitative Polymerase Chain Reaction (qPCR), the four main bacteria of the skin microbiota (Staphylococcus aureus, Staphylococcus epidermis, Cutibacterium acnes, and Streptococcus pyogenes). Samples will be collected before the start of treatment (visit 1), as well as after one week (visit 2) and two weeks of treatment (visit 3).
  2. This study will also aim to collect data on any potential adverse effects of the products.

研究类型

介入性

注册 (估计的)

10

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

  • 姓名:Anne-Julie Landry, M.Sc, M.Sc
  • 电话号码:418-360-7480
  • 邮箱:ajlandry@ircl.ca

学习地点

    • Quebec
      • Rimouski、Quebec、加拿大、G0K 1P0
        • SCF Pharma

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Participant aged of at least 18 years old.
  2. Participant diagnosed with eczema who did not use corticosteroids in the 14 days prior to study day 1;
  3. Available for the entire duration of the study and willing to participate based on the information provided in the ICF duly read and signed by the latter.
  4. Participant without intellectual problems likely to limit the validity of consent to participate in the study and compliance with protocol requirements, having the ability to cooperate adequately, understand and observe the instructions of research staff

Exclusion Criteria:

  • None

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:基础科学
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:MagOX topic treatment
Subjects will receive the daily treatment with MagOX serum and cream
Successive daily application of omega-3 monoglyceride based serum and cream on skin with eczema.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
To determine whether topical treatment with eicosapentaenoic acid monoglycerides can modulate the skin microbiota of eczema-affected skin
大体时间:2 weeks
Quantification of the skin microbiota by quantitative Polymerase Chain Reaction (qPCR) targeting the genome of four bacteria (Staphylococcus aureus, Staphylococcus epidermis, Cutibacterium acnes and Streptococcus pyogenes) on both treated and control skin area.
2 weeks

次要结果测量

结果测量
措施说明
大体时间
Assessment of potential adverse effects of treatment
大体时间:2 weeks
An adverse event will be reported for any change observed by the research nurse or declared by the subject in the health of the treated skin area.
2 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 首席研究员:Samuel Fortin, PhD、SCF Pharma

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年5月4日

初级完成 (估计的)

2026年12月4日

研究完成 (估计的)

2026年12月18日

研究注册日期

首次提交

2026年4月23日

首先提交符合 QC 标准的

2026年5月6日

首次发布 (实际的)

2026年5月13日

研究记录更新

最后更新发布 (实际的)

2026年5月13日

上次提交的符合 QC 标准的更新

2026年5月6日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • COS-PBP-03

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

The results of this research are the private property of SCF Pharma. If you are interested in the results of this study, you can contact Dr Samuel Fortin for a summary starting in summer 2027.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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