OLEOGEL-S10 TO ACCELERATE HEALING OF DONOR SITES: MONOCENTRIC RESULTS OF PHASE III CLINICAL TRIAL

Area of Science:

• Dermatology and wound healing research.
• Natural product pharmacology.

Background:

• Donor sites require effective wound healing treatments to minimize scarring and improve outcomes.
• Birch bark extracts, rich in triterpenes like betulin, have shown potential in dermatological applications.

Purpose of the Study:

• To evaluate the efficacy of Oleogel-S10, a betulin-rich triterpene extract from birch bark, in improving wound healing of donor sites.
• To assess scar quality and skin properties following treatment with Oleogel-S10.

Main Methods:

• A randomized, controlled, multicentre study involving 32 patients undergoing donor site harvesting.
• Oleogel-S10 was applied to donor sites, with outcomes compared to controls.
• Primary endpoint: time to wound closure. Secondary endpoints: scar assessment (POSAS, laser speckle contrast analysis, viscoelastic analysis) at closure, 3, and 12 months.

Main Results:

• Median wound closure time was 7 days for Oleogel-S10 versus 8 days for controls.
• Significantly lower Patient and Observer Scar Assessment Scale (POSAS) scores were observed in the Oleogel-S10 group at all time points.
• Improved scar perfusion and more favorable viscoelastic properties were noted in the Oleogel-S10 treated sites compared to controls.

Conclusions:

• Oleogel-S10 demonstrates significant effectiveness in accelerating donor site wound healing.
• The treatment leads to superior scar quality, including better perfusion and skin elasticity.
• Oleogel-S10 represents a promising therapeutic option for managing donor site wounds.