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临床试验/EUCTR2011-003132-30-SE
EUCTR2011-003132-30-SE进行中(未招募)不适用

Botulinum toxin treatment in craniofacial, inguinal, palmar, plantar and truncal hyperhidrosis, a randomized, double blind, placebo controlled study.

Svettmottagningen Hidroskliniken, Stockholm0 个研究点开始时间: 2011年7月19日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

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

  • The following inclusion criteria must be fulfilled prior to inclusion of the patient in the study:
  • Informed consent received from patient
  • Hyperhidrosis of the head, trunk, groins/buttocks, hands or feet
  • Age > 16 years
  • Patients must be previously untreated with Btx A/B
  • If female, patient is post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control
  • Patients must have DLQI-score = 10 and HDSS-score = 3 to be included in the study
  • Are the trial subjects under 18? yes
  • 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

  • If any of the below listed exclusion criteria are fulfilled, the patient must NOT be included in the study:
  • Contraindication to Btx
  • Use of aminoglycosides, tetracyklines , spectinomycin, lincomycin, polymyxin or muscle relaxants
  • Pregnancy or lactation
  • Patients unwilling to meet the requirements of the protocol

研究者

发起方
Svettmottagningen Hidroskliniken, Stockholm

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