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临床试验/DRKS00024552
DRKS00024552已完成4 期

Removal of fibromata pendulantia: scissor excision vs. 532 nm-laser - FibLas

Praxis Prof. Dr. Krengel/Dr. Mrowka/Dr. Haase0 个研究点目标入组 74 人开始时间: 2021年3月4日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
74

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 one(—)
性别
All

入选标准

  • 1. The clinical diagnosis is clearly fibromata pendulantia.
  • 2. The patient is at least 18 years old.
  • 3. The patient should be under sixty so that no high-risk patients have to be called into the doctor's office in times of the COVID-19 pandemic.
  • 4. The patient is able to understand and sign the patient information sheet and informed consent form.
  • 5. The patient is able to follow all study instructions and attend all study appointments.
  • 6. The patient is not pregnant and does not breastfeed.
  • 7. The patient is in good general health and is free from disease or physical complaints, e.g. other skin diseases, which, in the opinion of the investigator, might interfere with the evaluation of a target lesion or would expose the subject to unacceptable risk by participating in the study.

排除标准

  • 1. The patient is pregnant and/or breastfeeding.
  • 2. The patient is younger than 18 and older than 59 years.
  • 3. The patient has mental retardation, dementia and/or requires a legal guardian.
  • 4. The patient is not willing to abstain from unprotected sunbathing or tanning.
  • 5. The patient has a flurid or uncontrolled skin condition in the study area (e.g. psoriasis, eczema, or a skin condition (sunburn) that, in the opinion of the investigator, would endanger the patient if he/she participated in the study or could interfere with the study procedure.
  • 6. Severe coagulation disorders; ASA and Marcumar use are not exclusion criteria, Factor Xa antagonists can be paused 24 h before treatment.

研究者

发起方
Praxis Prof. Dr. Krengel/Dr. Mrowka/Dr. Haase

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