Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT00936533
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* Contraindication to Btx A
* Contraindication to general anaesthesia
* Use of aminoglycosides, tetracyclines , 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT00936533
Study Brief:
Protocol Section:
NCT00936533