The objective is to characterize the continued safety of SD-101 cream containing 6% allantoin in the treatment of the skin in patients with Simplex, Recessive Dystrophic, or JEB-nH EB.
This is an open label extension, multi-center, study to assess the continued safety of topically applied SD-101 cream containing (6% allantoin) across the entire skin surface in subjects with Simplex, Recessive Dystrophic, or Junctional non-Herlitz (JEB-nH) EB. SD-101 cream (containing 6% allantoin) will be applied topically, once a day to the entire body for a period of up to 1 year or until approval. Subjects who complete the SD-007 study will roll over into the SD-008 open label extension study. The baseline visit 1 for SD-008 will occur at the time of the final visit for SD-007. The safety evaluation from the SD-007 final visit will provide the baseline safety assessment for the SD-008 study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
SD-101 is a white, crystalline powder that is formulated within an odorless, soft, white cream base. SD-101-6.0 cream contains allantoin, a diureide glyoxylic acid, at a concentration of 6% and other excipients.
Measuring safety of SD-101-6.0
Evaluate the presence of Adverse Events of patients with Epidermolysis Bullosa using SD-101-6.0 Cream
Time frame: 1 Year
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