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临床试验/EUCTR2004-005194-27-AT
EUCTR2004-005194-27-AT进行中(未招募)1 期

Anti-inflammatory and/or antinociceptive effects of botulinum toxin A in an experimental inflammatory human skin pain model: a randomised, double blinded, placebo controlled study - UV-B and BoNT

Department of Neurology, Medical University of Vienna0 个研究点目标入组 6 人开始时间: 2008年2月25日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
6

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

  • Inclusion criteria
  • ·Men or women, aged between 19 and 75 years
  • ·Body mass index between 15th and 85th percentile
  • ·Normal findings in the medical history, physical and neurological
  • examination
  • ·without dermatological alterations on the upper legs in the area of
  • measurement
  • ·no exposure to Botulinum toxin for at least one year
  • 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
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Any of the following will exclude a subject from the study:
  • ·Previously exposed to Botulinum toxin
  • ·Regular use of anticholinergic medication especially anhidrotic drugs,
  • aminoglycosid antibiotics, abuse of alcoholic beverages
  • ·Participation in a clinical trial in the 2 weeks preceding the study
  • ·Symptoms of a clinically relevant illness in the 4 weeks before the first
  • ·Acute skin diseases on the relevant areas
  • ·Contraindications to botulinum toxin A: pregnancy, breast feeding, known
  • allergy or hypersensitivity, myasthenia gravis or Eaton-Lambert-syndrom,
  • myopathies and myotonias.

研究者

发起方
Department of Neurology, Medical University of Vienna

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