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. Allantoin is the active ingredient contained within SD-101 skin cream, which is a formulation with previously demonstrated stability of allantoin for several years at concentrations up to 9%. 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.
To enroll in the study, patients must meet the following inclusion criteria: they must have a signed informed consent form from a legal representative (with assent required, as all participants will be 12 years old or younger), and the patient or caretaker must be willing to follow all study requirements. Eligible participants must have a confirmed diagnosis of Simplex, Recessive Dystrophic, or JEB-nH EB; be between 28 days and 12 years old at study entry; have at least one target wound measuring 10–50 cm²; and present with a baseline wound burden of at least 5% body surface area.
Location 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 on the upcoming trial or potential interest in participation please email: [email protected]
The Dystrophic Epidermolysis Bullosa Research Association of America (DebRA), is the only national non-profit dedicated to funding research and providing services and programs for those with Epidermolysis Bullosa (EB) — “The Worst Disease You've Never Heard Of.”™
DEBRA International is a worldwide network of national groups working on behalf of those affected by epidermolysis bullosa (EB). On its site, you will find information about the condition, appropriate medical care, research into EB and living with EB as well as links to the national DEBRA groups around the world.
The DEBRA International vision is to ensure that people living with EB have access to the best quality support and medical care, while also driving the development of effective treatments and cures.
EB Research Partnership (EBRP) is the largest global organization dedicated to funding research to treat and cure Epidermolysis Bullosa (EB). On their site, you will find information regarding current research efforts and clinical trials, resources for EB patients and families, learn ways to become “EB Active”, and learn about current fundraising events being held across the US.
Stanford University School of Medicine’s Department of Dermatology has a long-standing program in EB research which is directed at developing new therapies for EB. Here, you can find information on their ongoing clinical trials and research projects, as well as links to their Pediatric, Children’s and Adult EB Clinics. There’s also an EB resources link with information about FAQ’s, wound care information and supplies, and information regarding multiple camps for children with severe skin conditions.
Epidermolysis Bullosa Center
Cincinnati Children’s EB Center is one of a few in the nation that provides comprehensive care for EB patients. Here, you can find information on their outpatient clinics, inpatient care, and consultations provided via telephone and e-mail. Under “Patients and Family”, they also include information on clinical trials and research studies, patient resources, vaccine resources and ongoing support resources.
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