Epidermolysis Bullosa Simplex Clinical Trial
Official title:
An International, Multicenter, Randomized, Double-Blind, Parallel-Group Phase 2 Study Evaluating the Safety and Efficacy of Diacerein 1% Ointment Topical Formulation in Subjects With Epidermolysis Bullosa Simplex
Epidermolysis bullosa simplex (EBS) is a rare genetic skin disease characterized by fragility of the skin and mucous membranes resulting in painful blisters and erosions after minor trauma. The purpose of this study is to compare the efficacy of diacerein 1% ointment to vehicle ointment when applied once-daily for 8 weeks in subjects with EBS.
The study is an international, multicenter, randomized, double-blind, vehicle-controlled,
parallel group study to evaluate the safety and efficacy of diacerein 1% ointment for the
treatment of subjects with EBS. Participants were assigned to study groups receiving either
diacerein 1% ointment or vehicle ointment for 8 weeks, followed by an 8 week follow-up
period. Approximately 80 subjects were to be randomized to one of the 2 treatment groups.
The primary objective of this study is to compare the efficacy of diacerein 1% ointment to
vehicle ointment based on reduction in body surface area (BSA) of EBS lesions being treated
when applied once-daily for 8 weeks in subjects with EBS. The secondary objectives are to
compare the effects of diacerein 1% ointment to vehicle ointment in subjects with EBS in
changes in Investigator Global Assessment (IGA) scores, pain, pruritus, mobility, and safety
and tolerability.
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