Epidermolysis Bullosa Clinical Trial
Official title:
An Open Label Extension, Multi-Center, Study to Evaluate the Safety of SD-101 Cream in Subjects With Epidermolysis Bullosa
The purpose of this study was to assess the continued safety of topical use of SD-101 cream
(6%) in participants with Epidermolysis Bullosa (EB).
Funding Source: FDA Office of Orphan Products Development
This was an open-label extension study to assess the continued safety of topically applied
SD-101 dermal cream (6%) in participants with Simplex, Recessive Dystrophic, and Junctional
non-Herlitz EB.
SD-101 dermal cream (6%) was applied topically, once a day to the entire body for the
duration of the study. Participants who successfully completed the entire SD-003 study
(NCT02014376) had the option to roll over into the SD-004 study (NCT02090283). The baseline
visit occurred at the final visit date for the SD-003 study. The body surface area (BSA)
coverage of blisters and lesions assessment made at the final SD-003 study visit were used as
the baseline information at the baseline visit for the SD-004 study. Participants returned to
the study site for the following 13 visits (36 months) to have BSA assessed. BSA was assessed
at all subsequent scheduled study center visits. Scheduled study center visits occurred every
6 months after Month 36 (Month 42, 48, and so on). After completion of Month 36, the next
participant visit (Month 39) was a phone call from the site to the participant. Telephone
visits occurred every 6 months thereafter (Month 45, 51, and so on) and included assessment
of adverse events and concomitant medications only. For female participants of childbearing
potential, a urine pregnancy test was performed at Month 6 and every 6 months up to and
including the final study visit.
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