A Phase 2B, Multi-center, Randomized, Double-Blind, Vehicle Controlled Study of the Effectiveness and Safety of SD-101 Cream in Subjects With Epidermolysis Bullosa
The purpose of this study is to assess whether SD-101 cream (3% or 6%) is effective in treating the lesions in subjects with Simplex, Recessive Dystrophic, or Junctional Epidermolysis Bullosa.
- drug : 3% SD-101 dermal cream
- drug : Vehicle (0% SD-101)
- drug : 6% SD-101 dermal cream
Phase: Phase 2
Ages Eligible For Study:
- Informed Consent form signed by the subject or the subject's legal representative; if the subject is under the age of 18 but capable of providing assent, signed assent from the subject. - Subject (or caretaker) must be willing to comply with all protocol requirements. - Diagnosis of Simplex, Recessive Dystrophic, or Junctional non-Herlitz EB. - Subjects must be 6 months of age and older. - Subjects must have 1 target wound within a prespecified size range at study entry - Target wound must be of at least a certain age