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) [EBShield Study]

Generalized Epidermolysis Bullosa Simplex (EBS)

The primary efficacy endpoint for this study is the proportion of patients achieving treatment success on the IGA of the Treatment Area, in which treatment success is defined as a score of 0 or 1 with at least a 2-point reduction from Baseline A (Visit 2/Day 1) to Week 8 (Visit 5/EOT).

Efficacy Endpoints: Change in % BSA of EBS lesion in the Treatment Area from Baseline A (Visit 2/Day 1) to Week 8 (Visit 5/EOT)., Efficacy Endpoints: Change in pain intensity scores from Baseline A (Visit 2/Day 1) to Week 8 (Visit 5/EOT)., Efficacy Endpoints: Change in pruritus intensity scores from Baseline A (Visit 2/Day 1) to Week 8 (Visit 5/EOT)., Efficacy Endpoints: Change in the QOLEB from Baseline A (Visit 2/Day 1) to Week 8 (Visit 5/EOT)., Efficacy Endpoints: Change in EBDASI score (skin activity) from Baseline A (Visit 2/Day 1) to Week 8 (Visit 5/EOT)., Safety Endpoints: Incidence and proportion of patients with AEs, including treatment emergent adverse events (TEAEs), and serious adverse events and relationship to the study medication., Safety Endpoints: Incidence and proportion of patients with mild, moderate, and severe AEs, Safety Endpoints: Change from Baseline A (Visit 2/Day 1) in clinical laboratory results in hematology, biochemistry, and urinalysis. (If the tests are omitted at Baseline A at the discretion of the investigator, the closest data during the screening period can serve as baseline.), Safety Endpoints: Change from Baseline A (Visit 2/Day 1) in vital signs, physical examination, and ECG parameters.(If the tests are omitted at Baseline A at the discretion of the investigator, the closest data during the screening period can serve as baseline.)

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