Epidermolysis Bullosa Clinical Trial
Official title:
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 was to assess whether the topical use of SD-101 cream (3% or 6%) was effective in treating wounds in participants with Simplex, Recessive Dystrophic, or Junctional non-Herlitz Epidermolysis Bullosa (EB).
This was a Phase 2b, multi-center, randomized, double-blind, vehicle-controlled study to
assess the efficacy and safety of SD-101 dermal cream (3% or 6%) on skin lesions in
participants with Simplex, Recessive Dystrophic, or Junctional non-Herlitz EB.
SD-101 cream [containing 3% or 6% or vehicle (0%)] was applied topically, once a day to the
entire body for a period of 90 days. Eligible participants had a target wound assessed at
baseline. Selected target wound had to be at least a certain age and within a prespecified
size range at study entry. Photographic confirmation of the target wound location was
collected at baseline, and the picture saved from the first visit was used to confirm
location of the target wound at subsequent visits. The participant returned to the study site
at Week 2, Month 1, Month 4, and Month 5 (at 14, 30, 60, and 90 days, respectively) to have
the target wound previously identified at baseline re-assessed for the level of healing. In
addition, changes in itching, pain, body surface area coverage of blisters and lesions, and
scaring of the healed target wound were also assessed at each visit.
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