跳至主要内容
临床试验/NCT03009903
NCT03009903Unknown不适用

Evaluation and Detection of Facial Propionibacterium Acnes Bacteria and Phage Using Pore Strips in Humans

MBcure Ltd0 个研究点目标入组 400 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
400
主要终点
Detection and analysis of facial P. acnes presence

研究概览

简要总结

This multi-center, outpatient study will extract and evaluate the presence of facial P. acnes bacteria and phage strains using pore strips on up to 400 human subjects.

详细描述

This multi-center, outpatient study will extract and evaluate the presence of facial P. acnes bacteria and phage strains using pore strips on up to 400 human subjects. An additional P. acnes visual detection method (VISIOPOR ® PP34N) will be used in this study as per PI decision to explore whether there is a correlation between P. acnes bacterial presence and fluorescent signal.

研究设计

研究类型
Observational

入排标准

年龄范围
14 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Adults between 14 to 50 years of age inclusive at the time of signing the informed consent
  • Able to provide written informed consent
  • Subjects who are willing to undergo pore strip treatment using the cosmetically acceptable pore strip product
  • Subjects who are willing to provide comprehensive demographic data using questionnaires

排除标准

  • Unwilling or unable to follow the procedures outlined in the protocol
  • Subjects treated with isotretinoin or tretinion during the 6 months prior to visit 1
  • Subjects treated with immunosuppressant agents
  • Pregnant subjects

结局指标

主要结局

Detection and analysis of facial P. acnes presence

时间窗: Day 0 and week 8 (optional)

次要结局

  • Assessing correlation between phage and P. acnes using: a. Demographic Questionnaire b. Visual Supportive Methodology (VISIOPOR ® PP34N) as per PI decision.(Day 0 and week 8 (optional)

研究者

发起方
MBcure Ltd
申办方类型
Industry
责任方
Sponsor

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