跳至主要内容
临床试验/NCT03465150
NCT03465150招募中不适用

Creation of a Monocentric Cohort of Patients Treated for Acne at the Nantes University Hospital: the COPACNE Cohort.

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年9月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Measure of Acne stage

研究概览

简要总结

With 24 million results associated with Google's searchon keywords "severe acne", Pr Dreno's team understand better thatthis disease, which affects many French people, is a real concern of Public Health and not a "forced evil" of the adolescent period, which will eventually resolve itself. Acne does not affect the vital prognosis, but its psychosocial impact is major and should not be underestimated. Paradoxically, despite the high prevalence of acne, few quality epidemiological studies have been published. Physicians are often helpless when faced with patients' questions. They often need a lot of explanations, especially on the factors aggravating this dermatosis, which greatly affects their quality of life.

This cohort, the first of its kind in France, will determine the predictive factors of therapeutic response, endogenous and environmental factors impacting on the severity of acne assess the quality of life and psychological impact of acne patients, determine the patient's course of care and the associated costs. Pr Dreno's team will also build up a bio collection (bacteriological samples).

详细描述

All patients going for the first time in specialized consultation "acne" at Nantes University Hospital , and who meet the inclusion criteria will be included in the COPACNE cohort. Inclusion will take place at the first consultation, after information and agreement of the patient and, if applicable, his or her legal representatives. The frequency of each patient's follow-up visits will be determined on a case-by-case basis according to the patient's medical needs (generally, the interval between 2 visits is between 1 and 4 months).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Patient with acne
  • •Patient (or parents/guardians for minors) who are not opposed to participating in the cohort.
  • •Subjects affiliated to an appropriate health insurance

排除标准

  • •Dermatosis of the face other than acne
  • •Refusal to participate by the minor or parent/guardian
  • •Adults under a legal protection regime (guardianship, trusteeship, judicial safeguard)

结局指标

主要结局

Measure of Acne stage

时间窗: 2 years

composite criteria. the scale is GEA for Global Evaluation Acne Scale with 0 no acne to 5 severe acne

次要结局

  • Bacteriological sample to find Propionibacterium acnes, Hormonal check-up on blood sample(2 years)
  • assessing patients' quality of life(2 years)
  • cost of acne illness(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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