Eli Sprecher, Mauricio Torres-Pradilla, Maria Florencia Fernandez, Christine Bodemer, Anna L Bruckner, Silvia Maria de Macedo Barbosa, Andrea Diociaiuti, Anna E Martinez, Francis Palisson, Miloš Nikolić, Asunción Vicente, Raúl de Lucas, Noemi Toiber Temin, Sandra Löwe, Johannes S Kern, Dédée F Murrell
{"title":"Long-Term Efficacy and Safety of Oleogel-S10 (Birch Triterpenes) for Pediatric Patients With Epidermolysis Bullosa.","authors":"Eli Sprecher, Mauricio Torres-Pradilla, Maria Florencia Fernandez, Christine Bodemer, Anna L Bruckner, Silvia Maria de Macedo Barbosa, Andrea Diociaiuti, Anna E Martinez, Francis Palisson, Miloš Nikolić, Asunción Vicente, Raúl de Lucas, Noemi Toiber Temin, Sandra Löwe, Johannes S Kern, Dédée F Murrell","doi":"10.1111/pde.70224","DOIUrl":null,"url":null,"abstract":"<p><strong>Background/objectives: </strong>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-S10 accelerated wound healing in EB. This prespecified subgroup analysis evaluated the long-term efficacy and safety of Oleogel-S10 in patients aged < 18 years from EASE.</p><p><strong>Methods: </strong>EASE comprised a 90-day double-blind phase (DBP) and 24-month open-label phase (OLP). In the DBP, patients were randomized 1:1 to receive Oleogel-S10 or control gel; all patients could enter the OLP and receive Oleogel-S10. Endpoints in this analysis included wound healing, total body wound burden, dressing change burden, and safety.</p><p><strong>Results: </strong>Overall, 156 pediatric patients were enrolled into the DBP (Oleogel-S10: n = 74; Control gel: n = 82); 147 entered the OLP. Oleogel-S10 resulted in 44.6% of pediatric patients with first complete target wound closure within 45 days, versus 25.6% with control gel (relative risk [95% CI]: 1.70 [1.11, 2.60], p = 0.012). Mean absolute body surface area percentage scores were 12.5% at DBP baseline and 5.3% at OLP Month 24 for the Oleogel-S10 group. Significantly more patients treated with Oleogel-S10 (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-S10 and control gel groups in the DBP, with most mild or moderate.</p><p><strong>Conclusions: </strong>These analyses of pediatric patients demonstrated accelerated wound healing, reduced frequency of dressing changes, and sustained reduction in wound burden up to 27 months. Long-term safety was consistent with the overall EASE population.</p><p><strong>Trial registration: </strong>NCT03068780, EudraCT 2016-002066-32; registered 3 March 2017; https://clinicaltrials.gov/study/NCT03068780 and https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-002066-32/GB.</p>","PeriodicalId":19819,"journal":{"name":"Pediatric Dermatology","volume":" ","pages":"1111-1119"},"PeriodicalIF":1.2000,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13617162/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pediatric Dermatology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1111/pde.70224","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2026/5/28 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"DERMATOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Background/objectives: 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-S10 accelerated wound healing in EB. This prespecified subgroup analysis evaluated the long-term efficacy and safety of Oleogel-S10 in patients aged < 18 years from EASE.
Methods: EASE comprised a 90-day double-blind phase (DBP) and 24-month open-label phase (OLP). In the DBP, patients were randomized 1:1 to receive Oleogel-S10 or control gel; all patients could enter the OLP and receive Oleogel-S10. Endpoints in this analysis included wound healing, total body wound burden, dressing change burden, and safety.
Results: Overall, 156 pediatric patients were enrolled into the DBP (Oleogel-S10: n = 74; Control gel: n = 82); 147 entered the OLP. Oleogel-S10 resulted in 44.6% of pediatric patients with first complete target wound closure within 45 days, versus 25.6% with control gel (relative risk [95% CI]: 1.70 [1.11, 2.60], p = 0.012). Mean absolute body surface area percentage scores were 12.5% at DBP baseline and 5.3% at OLP Month 24 for the Oleogel-S10 group. Significantly more patients treated with Oleogel-S10 (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-S10 and control gel groups in the DBP, with most mild or moderate.
Conclusions: These analyses of pediatric patients demonstrated accelerated wound healing, reduced frequency of dressing changes, and sustained reduction in wound burden up to 27 months. Long-term safety was consistent with the overall EASE population.
Trial registration: NCT03068780, EudraCT 2016-002066-32; registered 3 March 2017; https://clinicaltrials.gov/study/NCT03068780 and https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-002066-32/GB.
期刊介绍：
Pediatric Dermatology answers the need for new ideas and strategies for today''s pediatrician or dermatologist. As a teaching vehicle, the Journal is still unsurpassed and it will continue to present the latest on topics such as hemangiomas, atopic dermatitis, rare and unusual presentations of childhood diseases, neonatal medicine, and therapeutic advances. As important progress is made in any area involving infants and children, Pediatric Dermatology is there to publish the findings.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
