Betulin-Based Oleogel to Improve Wound Healing in Dystrophic Epidermolysis Bullosa: A Prospective Controlled Proof-of-Concept Study

الملخص EN

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 efficacy variable was faster reepithelialization as determined by 2 blinded experts.

The main secondary outcome variable of the study was percentage of wound epithelialization.

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 significance.

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 confirm significance.