跳至主要内容
临床试验/NCT03655197
NCT03655197已完成早期 1 期

Lipidome and Microbiome Profile of the Eye in Rosacea

University of California, Davis1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年11月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
30
试验地点
1
主要终点
Lipidome Change in Quantity

研究概览

简要总结

The question that the investigators aim to address in this proposal is how the local lipid mediator profiles of ceramides and eicosanoids are altered in cutaneous and ocular rosacea and how antibiotics alter the lipidome. The investigators also seek to understand how the microbiome is changed in those with and without rosacea, and how the microbiome is altered in those with rosacea. Understanding how the lipidome is modulated in rosacea with antibiotic treatment will serve as the first step in targeting therapies toward directly altering the lipidome to reduce inflammation and ultimately reduce the use of antibiotics.

详细描述

Rosacea is a common condition that has multiple subtypes that exhibit inflammation and deficits in the skin/eye barrier function. Cutaneous rosacea is estimated to have an incidence of 10-22% while the prevalence of ocular rosacea ranging from 6-72%. Although rosacea is not an infection, antibiotics are widely used as first-line therapy due to their anti-inflammatory and skin-barrier function supporting effects. The most common class of antibiotics used are the tetracyclines, such as doxycycline and minocycline. With the emergence of community acquired methicillin resistant Staphylococcus aureus (MRSA) as well as macrolide resistant Streptococci and Staphylococci, there is growing concern for the widespread use of antibiotics for non-infectious conditions.

The current clinical gap in practice is that there are few alternative therapies to antibiotics and this is partly due to our lack of understanding of what leads to the impaired skin/eye barrier and inflammation in rosacea. Few lipid-based studies have been performed in rosacea but there is early evidence for the importance in the lipidome to rosacea. The sebum in those with papulopustular rosacea was identified to have an abnormal profile to their sebum with a deficiency in long chain saturated fatty acids6 that correlates with the deficient skin barrier that is seen in rosacea. Treatment with minocycline was shown to restore skin barrier function in papulopustular rosacea but no lipid profile related measures were performed. Moreover, no studies have evaluated the role of other lipid mediators that are closely associated with the skin barrier and inflammation such as the ceramides and the eicosanoids.

The question that the investigators aim to address in this proposal is how the local lipid mediator profiles of ceramides and eicosanoids are altered in cutaneous and ocular rosacea and how antibiotics alter the lipidome. The investigators also seek to understand how the microbiome is changed in those with and without rosacea, and how the microbiome is altered in those with rosacea. Understanding how the lipidome is modulated in rosacea with antibiotic treatment will serve as the first step in targeting therapies toward directly altering the lipidome to reduce inflammation and ultimately reduce the use of antibiotics.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Ocular Rosacea Subjects

Experimental

Ocular rosacea subjects will receive mandatory Doxycycline intervention and will have samples collected at two visits, before starting intervention and at the completion of the intervention.

干预措施: Doxycycline (Drug)

Cutaneous Rosacea Subjects

Other

Doxycycline intervention is optional for cutaneous rosacea subjects. If they do not participate, samples will only be collected at one visit after Dove soap washout. If they do decide to participate, samples will also be collected after completion of the Doxycycline intervention.

干预措施: Doxycycline (Drug)

结局指标

主要结局

Lipidome Change in Quantity

时间窗: 1-5 weeks

Lipid profiles will be assessed, such as inflammatory and non-inflammatory lipid mediators, along with the alpha and beta diversity of the lipidome of the samples. The increase or decrease of inflammatory and non-inflammatory lipid mediators will be quantified.

Lipidome Change in Diversity

时间窗: 1-5 weeks

Lipid profiles will be assessed, such as inflammatory and non-inflammatory lipid mediators, along with the alpha and beta diversity of the lipidome of the samples. The shifts in diversity of the lipidome will be quantified.

Microbiome Change in Diversity

时间窗: 1-5 weeks

The microbiome content and the microbiome between sites on the same patient will be assessed. The assessment will examine what new bacteria becomes present.

Microbiome Change in Quantity

时间窗: 1-5 weeks

The microbiome content and the microbiome between sites on the same patient will be assessed. The assessment will examine how the previously present bacteria changes in quantity.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验