Introduction. Skin fragility and recurrent wounds are hallmarks of hereditary epidermolysis bullosa (EB). Treatment options to\naccelerate wound healing are urgently needed. Oleogel-S10 contains a betulin-rich triterpene extract frombirch bark. In this study,\nwe tested the wound healing properties of topical Oleogel-S10 in patients with dystrophic EB. Methods. We conducted an open,\nblindly evaluated, controlled, prospective phase II pilot trial in patients with dystrophic EB (EudraCT number 2010-019945-24).\nHealing of wounds treated with and without topical Oleogel-S10 was compared. Primary efficacy variable was faster reepithelialization\nas determined by 2 blinded experts. The main secondary outcome variable of the study was percentage of wound epithelialization.\nResults. Twelve wound pairs of 10 patients with dystrophic EB were evaluated. In 5 of 12 cases, both blinded reviewers\nconsidered epithelialization of the interventionwounds as superior. In 3 cases, only one reviewer considered Oleogel-S10 as superior\nand the other one as equal to control. Measurements of wound size showed a trend towards accelerated wound healing with the\nintervention but without reaching statistical significance. Conclusion. Our results indicate a potential for faster reepithelialization\nof wounds in patients with dystrophic EB when treated with Oleogel-S10 but larger studies are needed to confirm significance.
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