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临床试验/NCT03469076
NCT03469076Unknown不适用

Studie Van de Huidmicrobiota en Het Potentieel Van Een crème Met Probiotica Bij Personen Met Acne

University Hospital, Antwerp1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年4月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
Skin microbiome differences

研究概览

简要总结

In this study the topical use of cream with live probiotic bacteria was evaluated for its efficacy in reducing acne symptoms and its effect on the skin microbiota on patients with acne. Patients with mild to moderate acne used the probiotic cream for 8 weeks and clinical evaluation and sampling was done at start, 4, 8 and 10 weeks. Next-Generation Sequencing was used to analyze the skin microbiota of the patients.

详细描述

Probiotics are live micro-organisms which when administered in adequate amounts can exert a health benefit on the host. This health-promoting effects have been extensively studied in the gastrointestinal niche but it becomes more and more clear that other niches are also interesting for the potential of probiotics. Recent breakthroughs in 'next generation sequencing' (NGS) technologies are making it now possible to map the microbiota after DNA extraction, which is very interesting for bacteria that are not or difficult to cultivate. The research into the microbiota of the skin with such new NGS technologies currently limited, but shows that there is also an equilibrium in the skin composition of the microbiota and that there is a disturbance of the skin microbiota in acne (Murillo & Raoult, 2013). In acne vulgaris it is known that the condition is multifactorial and that both hormonal triggers and environmental factors play a role. However, it is also known that Propionibacterium acnes play an important role in the inflammation of the sebaceous gland follicles. Probiotic strains with antipathogenic activity against this bacterium and suitable for application to the skin is thus potentially able to restore the balance of the skin microbiota and reduce acne symptoms.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Years 至 25 Years(Child, Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •mild to moderate acne

排除标准

  • •local treatments, including cleansers, soaps, antimycotics and antibiotics within 2 weeks prior to start of study
  • •use of oral antibiotics within 4 weeks prior to start of study
  • •use of systemic retinoids within 6 months prior to start of study

研究组 & 干预措施

ACN Cream

Experimental

Patients with mild to moderate acne using ACN Cream

干预措施: YUN ACN Cream (Other)

结局指标

主要结局

Skin microbiome differences

时间窗: baseline; after 4 and 8 weeks of treatment; at 10 weeks, i.e. 2 weeks after stop of treatment

Analysis of the skin's microbiome at start (baseline) and after treatment with the ACN Cream

Clinical acne symptoms

时间窗: baseline, at 4, 8 and 10 weeks

Clinical evaluation of acne symptoms

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

Ethisch Comité, UZA

Prof. Julien Lambert, MD

University Hospital, Antwerp

研究点 (1)

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