This is a Phase 3, multi-center, randomized, double-blind, placebo controlled, study to assess the efficacy and safety of SD-101-6.0 cream vs. SD-101-0.0 (placebo) in the treatment of lesions in approximately 80 patients with Simplex, Recessive Dystrophic, or JEB-nH (Intermediate) EB. SD-101 cream is currently being developed as a new topical therapy for the treatment of wounds and lesional skin in patients with EB across the entire skin surface. The same product is foreseen for adult and pediatric patients.
SD-101-6.0 cream or placebo (SD-101-0.0) will be applied topically, once a day to the entire body for a period of 60 days. There will be 4 visits to the site over a 2-month period – baseline, 2 weeks, 1 month and 2 months. Assessment of target wound at all visits until the target wound is documented as closed. Assessment of itching will be evaluated at each visit. In addition, body surface area (BSA), and other secondary endpoints will be evaluated at the baseline and Month 2 visits.
Patients who complete participation in this 2-month study will be eligible to participate in an open label extension study (Study SD-008) beginning at the last visit in the SD-007 study with the ability to receive active therapy (SD-101-6.0).
Travel costs will be covered. Additional compensation may be provided.
