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
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