{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T04:56:01Z","timestamp":1790571361661,"version":"4.1.0"},"reference-count":21,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2026,5,28]],"date-time":"2026-05-28T00:00:00Z","timestamp":1779926400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,5,28]],"date-time":"2026-05-28T00:00:00Z","timestamp":1779926400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100007560","name":"Chiesi Farmaceutici","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007560","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pediatric Dermatology"],"published-print":{"date-parts":[[2026,9]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background\/Objectives<\/jats:title>\n                    <jats:p>Pediatric patients with epidermolysis bullosa (EB) experience lifelong complications, and wound healing is an important treatment goal. In the phase III EASE study (NCT03068780), Oleogel\u2010S10 accelerated wound healing in EB. This prespecified subgroup analysis evaluated the long\u2010term efficacy and safety of Oleogel\u2010S10 in patients aged &lt;\u200918\u2009years from EASE.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>EASE comprised a 90\u2010day double\u2010blind phase (DBP) and 24\u2010month open\u2010label phase (OLP). In the DBP, patients were randomized 1:1 to receive Oleogel\u2010S10 or control gel; all patients could enter the OLP and receive Oleogel\u2010S10. Endpoints in this analysis included wound healing, total body wound burden, dressing change burden, and safety.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Overall, 156 pediatric patients were enrolled into the DBP (Oleogel\u2010S10:\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200974; Control gel:\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200982); 147 entered the OLP. Oleogel\u2010S10 resulted in 44.6% of pediatric patients with first complete target wound closure within 45\u2009days, versus 25.6% with control gel (relative risk [95% CI]: 1.70 [1.11, 2.60],\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.012). Mean absolute body surface area percentage scores were 12.5% at DBP baseline and 5.3% at OLP Month 24 for the Oleogel\u2010S10 group. Significantly more patients treated with Oleogel\u2010S10 (38%) no longer required daily dressing changes versus control gel (9%) at DBP Day 90. Similar proportions of patients experienced adverse events in the Oleogel\u2010S10 and control gel groups in the DBP, with most mild or moderate.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>These analyses of pediatric patients demonstrated accelerated wound healing, reduced frequency of dressing changes, and sustained reduction in wound burden up to 27\u2009months. Long\u2010term safety was consistent with the overall EASE population.<\/jats:p>\n                    <jats:p>\n                      <jats:bold>Trial Registration:<\/jats:bold>\n                      NCT03068780, EudraCT 2016\u2010002066\u201032; registered 3 March 2017;\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/clinicaltrials.gov\/study\/NCT03068780\">https:\/\/clinicaltrials.gov\/study\/NCT03068780<\/jats:ext-link>\n                      and\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/www.clinicaltrialsregister.eu\/ctr-search\/trial\/2016-002066-32\/GB\">https:\/\/www.clinicaltrialsregister.eu\/ctr\u2010search\/trial\/2016\u2010002066\u201032\/GB<\/jats:ext-link>\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/pde.70224","type":"journal-article","created":{"date-parts":[[2026,5,28]],"date-time":"2026-05-28T07:29:46Z","timestamp":1779953386000},"page":"1111-1119","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Long\u2010Term Efficacy and Safety of Oleogel\u2010\n                    <scp>S10<\/scp>\n                    (Birch Triterpenes) for Pediatric Patients With Epidermolysis Bullosa"],"prefix":"10.1111","volume":"43","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4093-1032","authenticated-orcid":false,"given":"Eli","family":"Sprecher","sequence":"first","affiliation":[{"name":"Tel Aviv Sourasky Medical Center and Faculty of Medicine and Health Sciences, Tel Aviv University  Tel Aviv Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mauricio","family":"Torres\u2010Pradilla","sequence":"additional","affiliation":[{"name":"Department of Dermatology Hospital de San Jos\u00e9, Fundaci\u00f3n Universitaria de Ciencias de la Salud  Bogot\u00e1 Colombia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Florencia","family":"Fernandez","sequence":"additional","affiliation":[{"name":"Fundacion Respirar, Centro Medico Dra. De Salvo, Capital Federal  Buenos Aires Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christine","family":"Bodemer","sequence":"additional","affiliation":[{"name":"Department of Dermatology Expert Centre for Genodermatoses (MAGEC) Necker\u2010Enfants Malades Hospital, University Paris Centre, APHP  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2035-4127","authenticated-orcid":false,"given":"Anna L.","family":"Bruckner","sequence":"additional","affiliation":[{"name":"Department of Dermatology University of Colorado School of Medicine  Aurora Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Silvia Maria","family":"de Macedo Barbosa","sequence":"additional","affiliation":[{"name":"Pain and Palliative Care Unit, Instituto da Crian\u00e7a, Hospital das Cl\u00ednicas, Faculty of Medicine, Universidade de S\u00e3o Paulo  S\u00e3o Paulo S\u00e3o Paulo Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0879-9825","authenticated-orcid":false,"given":"Andrea","family":"Diociaiuti","sequence":"additional","affiliation":[{"name":"Dermatology Unit and Genodermatosis Research Unit Translational Pediatrics and Clinical Genetics Research Area, Bambino Ges\u00f9 Children's Hospital\u2010IRCCS  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna E.","family":"Martinez","sequence":"additional","affiliation":[{"name":"Department of Dermatology Great Ormond Street Hospital  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francis","family":"Palisson","sequence":"additional","affiliation":[{"name":"Department of Dermatology Faculty of Medicine, Cl\u00ednica Alemana\u2010Universidad del Desarrollo, Santiago, Chile Fundaci\u00f3n DEBRA Chile  Santiago Chile"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3926-5394","authenticated-orcid":false,"given":"Milo\u0161","family":"Nikoli\u0107","sequence":"additional","affiliation":[{"name":"Department of Dermatology and Venereology University of Belgrade School of Medicine; Clinic of Dermatology and Venereology, University Clinical Center of Serbia  Belgrade Serbia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Asunci\u00f3n","family":"Vicente","sequence":"additional","affiliation":[{"name":"Dermatology Unit, Hospital Sant Joan de D\u00e9u  Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7587-267X","authenticated-orcid":false,"given":"Ra\u00fal","family":"de Lucas","sequence":"additional","affiliation":[{"name":"Dermatology Unit, Hospital Universitario La Paz  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Noemi Toiber","family":"Temin","sequence":"additional","affiliation":[{"name":"Chiesi GRD Clinical Development  Toronto Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandra","family":"L\u00f6we","sequence":"additional","affiliation":[{"name":"Chiesi GRD  Dublin Ireland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6372-8048","authenticated-orcid":false,"given":"Johannes S.","family":"Kern","sequence":"additional","affiliation":[{"name":"The School of Translational Medicine, Monash University and Alfred Health  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D\u00e9d\u00e9e F.","family":"Murrell","sequence":"additional","affiliation":[{"name":"Department of Dermatology St George Hospital and Faculty of Medicine, University of New South Wales  Sydney New South Wales Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the EASE Study Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,5,28]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/bjd.18921"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jdin.2023.02.016"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13023-019-1279-y"},{"key":"e_1_2_12_5_1","unstructured":"European Medicines Agency \u201cFilsuvez EMA Summary of Product Characteristics \u201daccessed November 2025 https:\/\/www.ema.europa.eu\/en\/documents\/product\u2010information\/filsuvez\u2010epar\u2010product\u2010information_en.pdf."},{"key":"e_1_2_12_6_1","unstructured":"US Food and Drug Administration \u201cFilsuvez FDA Prescribing Information \u201daccessed November 2025 https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2023\/215064s000lbl.pdf."},{"key":"e_1_2_12_7_1","unstructured":"US Food and Drug Administration \u201cZevaskyn FDA Prescribing Information \u201daccessed October 2025 https:\/\/www.fda.gov\/media\/186511\/download?attachment."},{"key":"e_1_2_12_8_1","unstructured":"US Food and Drug Administration \u201cVyjuvek FDA Prescribing Information \u201daccessed November 2025 https:\/\/www.fda.gov\/media\/168350\/download."},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1093\/bjd\/ljac001"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.1093\/bjd\/ljaf022"},{"issue":"2","key":"e_1_2_12_11_1","first-page":"4","article-title":"Oleogel\u2010S10 (Birch Triterpenes) for the Treatment of Pediatric Patients With Epidermolysis Bullosa: Long\u2010Term Data From the Phase 3 EASE Study","volume":"42","author":"Bruckner A. 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