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 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).
- ICF form signed by the patient or patient's legal representative. Since all patients with be 12 years old or younger at study entry, signed assent from the patient’s legal representative will be required.
- Patient (or caretaker) must be willing to comply with all protocol requirements.
- Diagnosis of Simplex, Recessive Dystrophic, or JEB-nH.
- Patient must have 1 target wound (size 10 to 50 cm2)
- Patients must be between 28 days to 12 years at study entry
- Patients must have wound burden based on BSA of ≥5% at baseline
Information will be provided when final site selection is completed. Sites planned to participate will include the US, Canada, Europe, South America, Mexico, Malaysia and Australia.
For further information or if you have questions and are interested in participating in this upcoming clinical trial, please email Cure@Kapadi.com
