The goal of this clinical trial is to learn if Oleogel-S10 gel works to treat skin wounds from two types of inherited epidermolysis bullosa (EB): junctional EB (JEB) or dystrophic EB (DEB) in the Japanese population. Children and adults may participate. The trial also looks at the safety of Oleogel-S10 gel. The main questions it will answer are:
* Does Oleogel-S10 gel close wounds from JEB or DEB within 45 days or reduce the size of the wounds? * Are there any medical problems when using Oleogel-S10 gel? * How much of the drug ends up in your blood?
The study has 2 parts. In Part 1, participants will:
* Apply Oleogel-S10 gel to the EB wound dressings at least once every 4 days for 45 days. * Visit the clinic once every 2 weeks for checkups and tests. If participants complete Part 1, they may participate in Part 2 if they choose to. In Part 2, participants will continue to receive Oleogel-S10 gel until the product is available to buy in Japan or until the trial is stopped by the company.
Male or female aged ≥ 21 days
Confirmed diagnosis of either JEB or DEB
Both biological parents and all 4 grandparents of Japanese descent
All are located outside of the anogenital region
Hypersensitivity to Oleogel-S10 or any of its excipients
Diagnosis of EB subtypes simplex or Kindler EB
Receipt of systemic antibiotics for wound-related infections within 7 days prior to enrollment
Receipt of systemic or topical (on EB wounds) steroids within 30 days prior to enrollment Exceptions: Inhaled, ophthalmic, or mucosal applications, such as budesonide suspension for esophageal strictures
Single group
Oleogel-S10
DrugTopical gel
To evaluate the efficacy of Oleogel-S10 in Part I
The number and percentage of closed wounds within Part I (up to Day 45).
To continue to evaluate the efficacy of Oleogel-S10 up to Day 90 in Part II
Evaluations will include the proportion of participants achieving complete wound closure of at least one target wound, the change in surface area of the wound, patient and clinician impression of improvement, frequency of dressing changes, and incidence of wound infections.
To evaluate the safety and tolerability of Oleogel-S10 in Part I and Part II
Safety will be assessed through monitoring of adverse events, physical examinations, clinical laboratory tests (blood and urine samples), and vital signs from baseline up to study completion.
To evaluate the extent of systemic exposure to betulin
The concentration of betulin in blood at baseline and on Day 45.
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