Clinical Study Betulin-Based Oleogel to Improve Wound Healing in Dystrophic Epidermolysis Bullosa: A Prospective Controlled Proof-of-Concept Study Agnes Schwieger-Briel, 1,2 Dimitra Kiritsi, 1 Christoph Schempp, 1,3 Cristina Has, 1 and Hauke Schumann 1 1 Epidermolysis Bullosa Centre, Department of Dermatology, Medical Center, University of Freiburg, Freiburg, Germany 2 Department of Pediatric Dermatology, University Children’s Hospital Zurich, Zurich, Switzerland 3 Research Centre Skinitial, Department of Dermatology, Medical Center, University of Freiburg, Freiburg, Germany Correspondence should be addressed to Agnes Schwieger-Briel; agnes.schwieger@kispi.uzh.ch Received 20 February 2017; Accepted 18 April 2017; Published 22 May 2017 Academic Editor: Elizabeth H. Kemp Copyright © 2017 Agnes Schwieger-Briel et al. Tis is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Introduction. Skin fragility and recurrent wounds are hallmarks of hereditary epidermolysis bullosa (EB). Treatment options to accelerate 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 efcacy variable was faster reepithelial- ization as determined by 2 blinded experts. Te 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 reviewers considered epithelialization of the intervention wounds as superior. In 3 cases, only one reviewer considered Oleogel-S10 as superior and the other one as equal to control. Measurements of wound size showed a trend towards accelerated wound healing with the intervention but without reaching statistical signifcance. Conclusion. Our results indicate a potential for faster reepithelialization of wounds in patients with dystrophic EB when treated with Oleogel-S10 but larger studies are needed to confrm signifcance. 1. Introduction Epidermolysis bullosa (EB) comprises a heterogeneous group of inherited skin diseases characterized by skin fragility leading to recurrent wounds [1, 2]. Cutaneous and extra- cutaneous manifestations can result in severe morbidity and a reduced life expectancy [3–6]. Particularly in the generalized dystrophic EB subtypes, there is a signifcant risk of developing aggressive squamous cell carcinomas, with an increased incidence of metastases and death [7]. Up to now, no causal therapy in the sense of prevention of blister formation or improvement of skin stability is available. Treatment of EB mostly remains symptomatic [8] with optimal wound care and protection of the skin being the core therapeutic strategies. Wound care in these patients usually follows the “wound bed preparation model” [9–11], including the whole patient centered concerns [12], as well as local wound factors such as reduction of bacterial load and choice of optimal atraumatic dressings. Additional means to accelerate wound healing are urgently needed [13]. Birch (Betula species) is a medical plant. Its bark has been used as a natural remedy for skin diseases and wound care for centuries [14, 15]. Oleogel-S10 is a semisolid gel, containing 10% triterpene dry extract (TE) from Betulae cortex (birch bark) and refned sunfower oil (SFO) without the need for further excipients [16]. Both components have a low potential for allergic sensiti- zation and seem therefore suitable for use on wounds. To our knowledge, over the course of 10 years, there have been 2 cases of contact sensitization towards the triterpene extract, one of them being published [17]. Both patients known to us showed only a local skin reaction. No anaphylaxis has been reported. Hindawi Dermatology Research and Practice Volume 2017, Article ID 5068969, 10 pages https://doi.org/10.1155/2017/5068969