Botulinumtoxin A Treatment in Epidermolysis Bullosa Simplex and Pachyonychia congenita-a double-blind placebo-controlled phase II proof of concept study

Sophiahemmet0 个研究点开始时间: 2009年3月20日最近更新: 2012年3月19日

试验速览

暂无简介。

•Informed consent received from patient
•Informed consent received from patient´s parents (when patient < 18 years)
•A solid EBS-diagnosis based on genetic analysis and/or phenotype. The EBS-diagnosis will be performed by Professor Anders Vahlquist, Swedish Centre of Genetic skin disorders, Uppsala.
•Age > 16 years
•Patients must be previously untreated with Btx A
•If female, patient is post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control (i.e. a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom*) throughout the study. If male with a female partner of childbearing potential, willing to use an acceptable method of birth control for the study duration of the study, for both female and male, acceptable birth control must be used for at least 3 months after the last dose of study medication.* A condom alone is not considered an acceptable method for birth control. Two barrier methods only are not considered an acceptable method of birth control.
•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

•Contraindication to Btx A
•Contraindication to general anaesthesia
•Use of aminoglycosides, tetracyklines , spectinomycin, lincomycin, polymyxin or muscle relaxants
•Pregnancy or lactation
•Patients unwilling to meet the requirements of the protocol
•Other medical or social reasons for exclusion at the discretion of the Investigator

发起方

Sophiahemmet