Status:
UNKNOWN
Botulinumtoxin A Treatment in Epidermolysis Bullosa Simplex and Pachyonychia Congenita
Lead Sponsor:
Uppsala University
Conditions:
Epidermolysis Bullosa Simplex
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief Summary
This study evaluates the clinical effect of foot injection of the bacteria protein Botulinum toxin A on plantar pain in patients with EBS (epidermolysis bullosa simplex) or PC (pachyonychia congenita)...
Detailed Description
Epidermolysis bullosa simplex (EBS) is the most common subtype of epidermolysis bullosa and mutations in keratin genes (KRT 5/14) are responsible for this condition. Painful blisters and keratoderma o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00936533
Start Date
May 1 2009
End Date
December 1 2012
Last Update
March 9 2011
Active Locations (1)
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1
Svettmottagningen, Sofiahemmet
Stockholm, Sweden, SE - 114 86