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Betulin-based Oleogel to Improve Wound Healing in Dystrophic Epidermolysis Bullosa: a Prospective Controlled Proof-of-concept Study

Agnes Schwieger-BrielDimitra KiritsiChristoph Mathis SchemppCristina HasHauke Schumann

出版	Universität, 2017
URL	http://books.google.com.hk/books?id=DHiUzgEACAAJ&hl=&source=gbs_api

註釋Abstract: Clinical StudyBetulin-Based Oleogel to Improve Wound Healing inDystrophic Epidermolysis Bullosa: A Prospective ControlledProof-of-Concept StudyAgnes Schwieger-Briel,1,2Dimitra Kiritsi,1Christoph Schempp,1,3Cristina Has,1and Hauke Schumann11Epidermolysis Bullosa Centre, Department of Dermatology, Medical Center, University of Freiburg, Freiburg, Germany2Department of Pediatric Dermatology, University Children's Hospital Zurich, Zurich, Switzerland3Research Centre Skinitial, Department of Dermatology, Medical Center, University of Freiburg, Freiburg, GermanyCorrespondence should be addressed to Agnes Schwieger-Briel; agnes.schwieger@kispi.uzh.chReceived 20 February 2017; Accepted 18 April 2017; Published 22 May 2017Academic Editor: Elizabeth H. KempCopyright © 2017 Agnes Schwieger-Briel et al. This is an open access article distributed under the Creative Commons AttributionLicense, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properlycited.Introduction. Skin fragility and recurrent wounds are hallmarks of hereditary epidermolysis bullosa (EB). Treatment options toaccelerate wound healing are urgently needed. Oleogel-S10 contains a betulin-rich triterpene extract from birch bark. In this study,we tested the wound healing properties of topical Oleogel-S10 in patients with dystrophic EB.Methods. We conducted an open,blindly evaluated, controlled, prospective phase II pilot trial in patients with dystrophic EB (EudraCT number 2010-019945-24).Healing of wounds treated with and without topical Oleogel-S10 was compared. Primary efficacy variable was faster reepithelial-ization as determined by 2 blinded experts. The main secondary outcome variable of the study was percentage of wound epithe-lialization.Results. Twelve wound pairs of 10 patients with dystrophic EB were evaluated. In 5 of 12 cases, both blinded reviewersconsidered epithelialization of the intervention wounds as superior. In 3 cases, only one reviewer considered Oleogel-S10 as superiorand the other one as equal to control. Measurements of wound size showed a trend towards accelerated wound healing with theintervention but without reaching statistical significance.Conclusion. Our results indicate a potential for faster reepithelializationof wounds in patients with dystrophic EB when treated with Oleogel-S10 but larger studies are needed to confirm significance