Wednesday, October 31, 2012
Ferrer, a privately-held Spanish pharmaceutical company, has received approval to initiate phase III clinical trials of ozenoxacin formulated as a topical treatment for infectious dermatological conditions. The first patients are expected to enter the trials in February 2012 and the studies are scheduled to conclude in the first quarter of 2013.
The randomized, placebo-controlled, parallel, double-blinded, superiority clinical study will compare ozenoxacin 1% cream versus a placebo. The trial will be conducted in about 465 patients up to two years old with a clinical diagnosis of non-bullous or bullous impetigo. Fifty centers will be participating in the study in the U.S., South Africa, Germany, Romania, India and Ukraine.