Epidermolysis Bullosa Clinical Trial
Official title:
An Open Label Multi-Center Extension Study to Evaluate the Long-term Safety of Zorblisa™ (SD-101-6.0) in Patients With Epidermolysis Bullosa
The study aimed to assess the long-term safety of topical use of Zorblisa (SD-101-6.0) in participants with Epidermolysis Bullosa (EB).
This was an open label, multi-center extension study to assess the long-term safety of
topically applied SD-101-6.0 in participants with simplex, recessive dystrophic, and
junctional non-Herlitz EB. SD-101-6.0 was applied topically once a day to the entire body.
The planned duration of treatment with SD-101-6.0 for Study SD-006 was up to 48 months, with
a safety follow-up period of 30 days; however, the study was terminated early by the sponsor.
The maximum study duration completed by at least 1 participant, treatment and safety
follow-up, was 37 months.
Participants who successfully completed Study SD-005 had the option to rollover into Study
SD-006. The screening/baseline visit (Visit 1) occurred at Visit 5 (approximately 90 days
from baseline) of Study SD-005. The Body Surface Area (BSA) assessments of lesional skin and
wound burden performed at Visit 5 (approximately 90 days from baseline) for Study SD-005 were
utilized as the baseline assessments for Study SD-006. Participants returned for follow-up
visits at Month 1 then every 3 months.
At each visit, assessments included BSA of lesional skin and wound burden. For target wounds
that are not closed by the end of Study SD-005, the ARANZ picture and calculation of target
wound area at the final visit for Study SD-005 was used as the baseline area size of the
target wound for Study SD-006. These unhealed target wounds from Study SD-005 were assessed
via ARANZ SilhouetteStar™ at each subsequent scheduled visit until the target wound was
documented as closed. Closed wounds were assessed for scarring.
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