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Table 1 Primary and secondary outcome measures

From: Oleogel-S10 Phase 3 study “EASE” for epidermolysis bullosa: study design and rationale

Primary endpoint • Proportion of patients with complete closure of the target wound within 45 ± 7 days of treatment
Secondary endpoints • Time to wound closure up to 90 ± 7 days of treatment
(key secondary endpoint)
• Incidence of first complete wound closure of EB target wound at different time points (see Fig. 2)
• Change from baseline in EB target wound size
• Change in total body wound burden over time
• Change in percentages of TBSA affected by EB partial thickness wounds
Patient-reported outcomes • Change from baseline in background and procedural pain after wound dressing change
• Change from baseline in itching before wound dressing change
• Response to treatment
• Change from baseline in sleep quality
• Number of days missed from school or work
Safety endpoints • Incidence, severity, and relatedness of AEs
• Local tolerability
• Laboratory findings
• Incidence and severity of wound infections
  1. AE adverse event, EB epidermolysis bullosa, TBSA total body surface area