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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