An International, Multicenter, Randomized, Double-Blind, Parallel Group, Vehicle-Controlled, Phase 2/3 Study with Open-Label Extension Evaluating the Efficacy and Safety of Diacerein 1% Ointment for the Treatment of Generalized Epidermolysis Bullosa Simplex (EBS)
- Population: Patients aged 6 months or older
- Study Condition: Generalized Epidermolysis Bullosa Simplex (EBS)
- Study Design: This study consists of two parts. Part A is a randomized, double-blind, parallel group, vehicle-controlled phase 2/3 study to evaluate the efficacy and safety of diacerein 1% ointment after 8 weeks of treatment in generalized EBS. Part B is a single-arm, open-label, 24-week extension phase to evaluate the long-term safety of diacerein 1% ointment in patients with generalized EBS.
- Duration: Approximately 40 to 44 weeks
- Compensation may be provided for participation.