Moberg Derma Initiates Phase II Trial With Limtop Following Positive Phase I Results
Published: May 02, 2012
STOCKHOLM--(BUSINESS WIRE)--Regulatory News: The German Federal Institute for Drugs and Medical Devices (BfArM) has granted Moberg Derma (STO:MOB) approval to initiate a clinical phase II trial for Limtop. The aim is to evaluate the efficacy and safety of three different dose regimens of Limtop in a study involving 96 patients with Actinic Keratosis (AK) on the head or face. The results are expected in the first half of 2013. The approval was granted following positive results from a phase I study on 30 healthy volunteers who were treated daily for 21 days. No serious treatment-related adverse events were observed.