Abstract
This review analyses the mechanism of action and clinical efficacy of a triterpene complex (birch bark extract), the first product for pathogenetic treatment of wounds associated with dystrophic and junctional congenital epidermolysis bullosa. Biologically active components of the triterpene complex affect key stages of the wound process by modulating the inflammatory phase, regulating cytokine and chemokine production, stimulating keratinocyte migration and differentiation, and promoting restoration of dermo-epidermal cohesion. These effects are aimed at correcting the impaired wound healing mechanisms typical for patients with congenital epidermolysis bullosa. The clinical efficacy of the pathogenetic treatment has been demonstrated in the international, randomized, double-blind, phase III trial (EASE), in which the administration of the gel containing the triterpene complex resulted in statistically significant accelerated wound closure, reduced pain severity during dressing changes, and decreased frequency of dressing changes. A favourable safety profile and sustained clinical effect were confirmed in the 24-month open-label study phase as well as in the clinical observations in real-world settings. Thus, the administration of the gel containing the triterpene complex is a pathogenetically justified approach to the treatment of chronic cutaneous wounds in patients with congenital epidermolysis bullosa.