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- Title
Oleogel-S10 Phase 3 study "EASE" for epidermolysis bullosa: study design and rationale.
- Authors
Kern, Johannes S.; Schwieger-Briel, Agnes; Löwe, Sandra; Sumeray, Mark; Davis, Charles; Martinez, Anna E.
- Abstract
<bold>Background: </bold>Epidermolysis bullosa (EB) is a group of rare, genetic diseases that affect the integrity of epithelial tissues, most notably the skin. Patients experience recurrent skin wounding, with severity depending on type, sub-type, and mutation. Oleogel-S10, a formulation of birch bark extract, has demonstrated efficacy in a Phase 2 trial assessing re-epithelialization of wounds in EB. EASE (NCT03068780, EudraCT 2016-002066-32) is a randomized, Phase 3, placebo-controlled study designed to determine the efficacy of Oleogel-S10 versus placebo in patients with EB.<bold>Methods: </bold>EASE is a Phase 3, two-phase study comprising a 90-day, double-blind, randomized, placebo-controlled phase, followed by 24 months of open-label, single-arm follow-up. Patients with junctional EB, dystrophic EB, or Kindler syndrome and target wounds (10 - 50cm2) present for > 21 days and < 9 months, are randomized in a 1:1 ratio to receive wound dressings according to local standard of care with or without Oleogel-S10. Placebo is based on the Oleogel-S10 vehicle, which is sunflower oil formulated to have a consistency indistinguishable from that of the active product. The primary endpoint of the trial, directed by the US health authority according to the required study endpoints for chronic cutaneous ulcer and burn wounds, is to compare the efficacy of Oleogel-S10 versus placebo according to the proportion of patients with complete closure of the target wound within 45 ± 7 days of treatment. Additional EB-focused endpoints include wound burden, patient-reported outcomes, and safety.<bold>Results: </bold>Results of the primary endpoint are anticipated to be available by H2 2019.<bold>Trial Registration: </bold>ClinicalTrials.gov, NCT03068780 . EudraCT, 2016-002066-32. Registered on 3 March 2017.
- Subjects
EPIDERMOLYSIS bullosa; GENETIC disorders; SUNFLOWER seed oil; SKIN injuries; EPITHELIUM; GRANULATION tissue; BIRCH bark extract; THERAPEUTIC use of plant extracts; BARK; CLINICAL trials; COMPARATIVE studies; EXPERIMENTAL design; RESEARCH methodology; MEDICAL cooperation; ORGANIC compounds; PATIENT satisfaction; PLANTS; QUALITY of life; RESEARCH; EVALUATION research; RANDOMIZED controlled trials; BLIND experiment
- Publication
Trials, 2019, Vol 20, Issue 1, p1
- ISSN
1745-6215
- Publication type
journal article
- DOI
10.1186/s13063-019-3362-z