Accelerated reepithelialization by triterpenes: proof of concept in the healing of surgical skin lesions.

The acceleration of wound healing is a major surgical concern. A triterpene extract from birch bark (Betulae cortex) experimentally enhances keratinocyte differentiation in vitro and accelerates wound healing ex vivo. We conducted an open, blind-evaluated, controlled, prospective, randomized (1:1) phase II clinical trial in patients requiring split-thickness skin graft transplantation at two university hospitals in Germany. Donor sites on the upper legs were covered with a moist silicone-coated dressing. Oleogel-S10 ointment containing 10% birch bark extract was randomly applied to the distal or proximal half of the wound, with the other half serving as an intraindividual control, for 14 days after the skin graft surgery. The primary efficacy variable was faster reepithelialization as determined from macrophotographs by independent, blinded experts. Twenty-four patients were randomized and completed the trial. After the 14-day test period, the planned interim analysis revealed a highly significant (p < 0.0001) superiority of Oleogel-S10 in the primary efficacy variable and the trial was terminated early due to ethical concerns. The treatment side was also better reepithelialized and more similar to normal skin after 3 months. In conclusion, Oleogel-S10 significantly accelerated reepithelialization at split-thickness skin graft donor sites. Treatment with Oleogel-S10 was safe and well tolerated.

Accelerating the aesthetic benefit of wound healing by triterpene.

Intention of the study (EudraCT No 2009-017418-56) is a proof of aesthetic benefit of triterpene treatment in superficial wounds. In an open, prospective, controlled, randomized, blindly evaluated multicentre phase II clinical trial a triterpene ointment (OG-S10) is compared intra individually with a state-of-the-art moist wound healing dressing (Mepilex(®)) in split thickness skin graft donor sites. The graft wound areas at the upper leg were divided into two equal halves, one proximal and one distal site. Decided by randomization the one site was treated with triterpene and the other in comparison with moist dressing. Triterpene treatment went on for 14 days as covering the wound at every change of wound dressing with the ointment (100 mg/cm(2)). The comparative treatment went on as covering the site by this dressing alone. The outcome of these different treatments was evaluated by two blindly observing distant experts on the basis of photographs of the wound healing progress. Photographs were taken day 14, 3 month and 1 year after treatment. The only criterion for evaluation of the two sites was similarity of the wound area to the surrounding skin in terms of colour and texture: which of the two sites, the proximal or the distal, was aesthetically superior in normal skin appearance after 14 days at the end of treatment, after 3 month of follow up and 1 year after treatment? The descriptive comparison is demonstrating quite a remarkable advantage of the ointment versus the moist wound dressing in promoting wound healing: even having in mind the small number of 24 patients within the protocol, the superiority of aesthetic benefit by triterpene treatment after 14 days (22 out of 24 patients), after 3 month (15 out of 19 patients) and after 1 year (8 out of 10 patients) is obvious.

Arnica and stinging nettle for treating burns - a self-experiment.

BACKGROUND AND OBJECTIVE: Combudoron, composed of extracts from arnica and stinging nettle, is used for the treatment of partial thickness burns and insect bites in Europe. Because clinical investigations are lacking we wanted to investigate its efficacy in partial thickness burns. METHODS: Two individuals performed a self experiment: 4 experimental grade 2 burns (each 1 cm(2)) on the back were induced respectively with an erbium YAG-laser. Wounds were treated with Combudoron gel, Combudoron liquid, placebo gel or placebo liquid in each of the subjects in a standardized, single blind manner. Outcome parameters were the photo documented duration of wound healing and visual analogue scale (VAS) pain scores. RESULTS: All 8 experimental burns were similar from size and depth at baseline. Eschars of the verum-treated burns fell off earlier than the placebo-treated burns (verum liquid: after 14 and 19 days compared to 17 and 27 days with placebo liquid. Verum gel: after 16 and 22 days compared to 18 and 28 days with placebo gel). Eschars of the liquid treated burns fell off earlier than of the gel treated burns. Pain scores were not applicable because they were low and differences between the lesions could not be discriminated on the back. CONCLUSION: Combudoron seems to have positive effects on healing of grade 2 laser induced burns which deserve further investigation.