Oleogel-S10 in Wound Healing of Split-Thickness Skin Graft Donor Sites (BSG-12)

Phase 3 Completed 112 enrolled Birken AG

RandomizedSingle-groupSingle-blindTreatment

Summary

The main purpose of this phase III clinical trial was to show safety and efficacy of Oleogel-S10 in accelerating the wound healing of Split-Thickness Skin Graft (STSG) donor sites.

Timeline

Start: 2013-03
Primary completion: 2013-09
Completion: 2014-09

Publications

Background Barret JP, Podmelle F, Lipovy B, Rennekampff HO, Schumann H, Schwieger-Briel A, Zahn TR, Metelmann HR; BSH-12 and BSG-12 study groups. Accelerated re-epithelialization of partial-thickness skin wounds by a topical betulin gel: Results of a randomized phase III clinical trials program. Burns. 2017 Sep;43(6):1284-1294. doi: 10.1016/j.burns.2017.03.005. Epub 2017 Apr 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BIRCH TRITERPENES	Small molecule	100 mg	—

Indications

No indication recorded.