Diacerein for butterfly children

Diacerein for the treatment of Epidermolysis bullosa simplex - Diacerein for EBS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002034-21-AT

Enrollment

Unknown

Registered

2013-08-01

Start date

2013-12-16

Completion date

Unknown

Last updated

2017-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epidermolysis bullosa simplex - type Dowling-Meara

Interventions

Product Name: SimpleCare Pharmaceutical Form: Cream INN or Proposed INN: DIACEREIN CAS Number: 13739-02-1 Concentration unit: g gram(s) Concentration type: equal Concentration number: 10- Pharmaceutic

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
Secondary end point(s): Time span until reaching the initial blister number (+/- 10%).;Timepoint(s) of evaluation of this end point: After 16 weeks.	—

Countries

Austria

Contacts

Public ContactEB House Austria

EB House Austria

jo.bauer@salk.at+4366244823110

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026