Diacerein for butterfly childre
- Conditions
- Epidermolysis bullosa simplex - type Dowling-MearaTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2013-002034-21-AT
- Lead Sponsor
- EB House Austria
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- Epidermolysis bullos simplex - type Dowling-Meara
- Mutations in either the keratin 14 or the keratin 5 gene, leading to protein aggregation
- Age: 6-19
Are the trial subjects under 18? yes
Number of subjects for this age range: 14
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Other types of EB with mutations in the keratin 14 or teh keratin 5 gene.
- participation in another clinical trial at the same time
- known intolerance against diacerein, adjuvants (especially Tartrazine) or other substances with similar structures
- pregnancy or lactation
- relevant other illnesses (acute infections, ...)
- patients with impaired liver functions
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Reduction of blister numbers on the treated body surface by 40% in the diacerein group in comparison to placebo within 4 weeks.;Secondary Objective: Time until the reaching of the initial blister number (+/-10%) during the follow-up phase.;Primary end point(s): Reduction of blister numbers in the treated area by 40% in comparison to placebo;Timepoint(s) of evaluation of this end point: After 4 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Time span until reaching the initial blister number (+/- 10%).;Timepoint(s) of evaluation of this end point: After 16 weeks.