Diacerein for the treatment of epidermolysis bullosa simplex
Phase 2
- Conditions
- Q81.0Epidermolysis bullosa simplex
- Registration Number
- DRKS00005412
- Lead Sponsor
- Division of Experimental Dermatology and EB House AustriaDepartment of DermatologyUniversity Hospital SalzburgParacelsus Medical UniversityUniversity Hospital for Dermatology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 17
Inclusion Criteria
An age between 4 and 19 years
- Diagnosis of EBS-DM.
- Mutations in the keratin 5 or keratin 14 gene
- signed consent form
Exclusion Criteria
- other types of EB with mutations in the keratin 5 or keratin 14 gene.
- lack of mutation analysis
- Known or expected intolerance to diacerein a component of the cream (e.g. tartrazin) or substances with a similar structure
- Pregnancy or lactation
- Contemporaneous participation in another clinical trial.
- Patients with hepatic dysfunction
- Relevant other diseases (e.g. acute infections, ...)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction of blisters within four weeks by 40% in the verum group, in comparison to the placebo group.
- Secondary Outcome Measures
Name Time Method Time span until the reaching of the initial blister number (+/-10%) during the follow-up.