Table 1.

Primary and secondary outcome measures

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

AE adverse event, EB epidermolysis bullosa, TBSA total body surface area