{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T05:07:04Z","timestamp":1791868024750,"version":"4.3.4"},"reference-count":35,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2022,10,20]],"date-time":"2022-10-20T00:00:00Z","timestamp":1666224000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,1,23]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Epidermolysis bullosa (EB) is a heterogeneous group of rare, difficult-to-treat, inherited multisystem diseases affecting epithelial integrity. Patients with EB are affected by mechanical fragility of epithelial surfaces including the skin and, as a result, extensive recurrent blistering is a characteristic of the condition. Chronic wounds predispose patients with EB to the development of squamous cell carcinoma, which is a major cause of premature death.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>EASE was a double-blind, randomized, vehicle-controlled, phase III study to determine the efficacy and safety of the topical gel Oleogel-S10 (birch triterpenes) in EB. EASE was funded by Amryt Research Limited.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Patients with dystrophic EB, junctional EB or Kindler EB and a target partial-thickness wound lasting \u2265 21 days and &amp;lt;\u00a09 months that was 10\u201350 cm2, were enrolled and randomized via computer-generated allocation tables 1 : 1 to Oleogel-S10 or control gel \u2013 both with standard-of-care dressings. Study gel was applied to all wounds at least every 4 days. The primary endpoint was the proportion of patients with first complete closure of target wound within 45 days.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>A total of 223 patients were enrolled and treated (109 treated with Oleogel-S10, 114 with\u00a0control\u00a0gel). The primary endpoint was met; Oleogel-S10 resulted in 41\u00b73% of patients with first complete target wound closure within 45 days, compared with 28\u00b79% in the control gel arm (relative risk 1\u00b744, 95% confidence interval\u00a0(CI) 1\u00b701\u20132\u00b705; P = 0\u00b7013). Adverse events (AEs) occurred with similar frequency for Oleogel-S10 (81\u00b77%) compared with control gel (80\u00b77%). AEs were predominantly of mild-to-moderate intensity (4\u00b76% were severe).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Oleogel-S10 is the first therapy to demonstrate accelerated wound healing in EB. Oleogel-S10 was well \u00adtolerated.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/bjd\/ljac001","type":"journal-article","created":{"date-parts":[[2023,1,20]],"date-time":"2023-01-20T14:12:33Z","timestamp":1674223953000},"page":"12-21","source":"Crossref","is-referenced-by-count":83,"title":["Efficacy and safety of Oleogel-S10 (birch triterpenes) for epidermolysis bullosa: results from the phase III randomized double-blind phase of the EASE study"],"prefix":"10.1093","volume":"188","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6372-8048","authenticated-orcid":false,"given":"Johannes S","family":"Kern","sequence":"first","affiliation":[{"name":"Dermatology Department, Royal Melbourne Hospital, Faculty of Medicine, Dentistry and Health Science, The University of Melbourne , Parkville, VIC , Australia"},{"name":"Department of Dermatology, Alfred Hospital, Central Clinical School, Monash University , Melbourne , Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eli","family":"Sprecher","sequence":"additional","affiliation":[{"name":"Division of Dermatology, Tel Aviv Sourasky Medical Center , Tel Aviv , Israel"},{"name":"Sackler Faculty of Medicine, Tel Aviv University , Tel Aviv , Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Florencia","family":"Fernandez","sequence":"additional","affiliation":[{"name":"Fundacion Respirar, Centro Medico Dra. 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USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles","family":"Davis","sequence":"additional","affiliation":[{"name":"CSD Biostatistics Inc. , Oro Valley, AZ , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Sumeray","sequence":"additional","affiliation":[{"name":"Amryt Research Limited , Dublin , Ireland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna\u00a0L","family":"Bruckner","sequence":"additional","affiliation":[{"name":"University of Colorado School of Medicine, Department of Dermatology , Aurora, CO , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2971-0199","authenticated-orcid":false,"given":"D\u00e9d\u00e9e F","family":"Murrell","sequence":"additional","affiliation":[{"name":"Department of Dermatology, St. George Hospital, University of New South Wales , Sydney, NSW , 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