Inherited connective tissue disease
Conditions
Interventions
ZORBLISA will be applied topically, once a day, to the entire body for a period
of 630 days.
Junctional non Herlitz EB
Simplex Epidermolysis Bullosa (EB) Recessive Dystrophic EB
Sponsors
Scioderm Inc.
Eligibility
Age
2 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Informed Consent form signed by the subject or subject's legal representative; if the subject is under the age of 18 but capable of providing assent, signed assent from the subject. 2. Subject (or caretaker) must be willing to comply with all protocol requirements. 3. Patients who completed the SD-005 study (on study drug at Visit 5).
Exclusion criteria
Exclusion criteria: 1. Patients who do not meet the entry criteria outlined above. 2. Pregnancy or breastfeeding during the study. (A urine pregnancy test will be performed at the final visit for SD-005 for female patients of childbearing potential) 3. Females of childbearing potential who are not abstinent or not practicing a medically acceptable method of contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to demonstrate the longterm safety of ZORBLISA in patients, with Simplex, Recessive Dystrophic, and Junctional non-Herlitz Epidermolysis Bullosa. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are to assess the efficacy of ZORBLISA in terms of the change in Body Surface Area (BSA) of lesional skin and wound burden; as well as closure of unhealed target wounds from the SD-005 study. | — |
Countries
Australia, Austria, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom, United States of America
Outcome results
None listed