A Phase 2 Study of TCP-25 Gel in Patients With Epidermolysis Bullosa, STEP-study

Exclusion Criteria

• •The patient has any subtype of EB other than DEB or JEB.
• •The patient is currently being treated or planned to be treated with systemic antibiotics.
• •Note: Use of preventive and/or anti-inflammatory antibiotic treatment, including doxycycline, on an established treatment regimen (stable dose for ≥6 weeks before the Baseline Visit) is permitted. Use of topical antibiotics on the index wounds within 7 days before the Baseline Visit is prohibited.
• •Use of systemic corticosteroids \>0.2 mg/kg prednisone dose equivalent per day within 30 days or use of topical corticosteroids on index wounds within 7 days before the Screening Visit.
• •Note: Corticosteroids for inhalation, ophthalmic, or intranasal use are permitted.
• •The patient has a history of or current malignancy over the index wound, eg, basal cell carcinoma or squamous cell carcinoma.