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临床试验/EUCTR2021-000304-38-FR
EUCTR2021-000304-38-FR进行中(未招募)1 期

Tumescent anesthesia efficiency in pain management during a dynamic phototherapy session in vertex actinic keratosis treatment: a single-center prospective randomized study.

CHU de Poitiers0 个研究点目标入组 48 人开始时间: 2021年2月15日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
48

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • - Patients over the age of 18
  • - Diagnosis of clinical or histological actintic keratoses validated by a dermatologist
  • - More than 4 vertex actinic keratoses lesions that can be treated with a dynamic phototherapy session
  • - Free subject, without guardianship or curatorship or subordination
  • - Person affiliated or beneficiary of a social security plan
  • - Informed and signed consent by the patient after clear and fair information about the study
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 20
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 28

排除标准

  • - Patients with recurrent porphyria
  • - Severe hepato-cellular insufficient patients
  • - Kidney failure patients
  • - Patients who have received treatment for actinic keratoses in the last three months (cryotherapy, 5-fluorouracil, imiquinod, daylight-PTD)
  • - Patients who have already participated in this study
  • - People who do not have a social security plan or do not benefit from it through a third party.
  • - Persons with enhanced protection, namely minors, persons deprived of their liberty by judicial or administrative decision, persons staying in a health or social institution, adults under legal protection and finally the sick in an emergency situation.
  • - Pregnant or lactating women, women of childbearing age who do not have effective contraception (hormonal/mechanical: per bone, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy).
  • - Concurrent participation in another clinical research study.

研究者

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