Ferrer has announced that the first patient has been recruited into a second phase III trial of Ozenoxacin, formulated as a topical treatment for infectious dermatological conditions in adult and paediatric patients with impetigo. The study is scheduled to complete in Q1, 2015.
The multicenter, randomized, double-blinded, clinical study comparing Ozenoxacin one per cent cream versus placebo will be conducted in about 412 patients aged two months and over with a clinical diagnosis of non-bullous or bullous impetigo at approximately 36 centres in the USA, South Africa, Germany, Spain, Romania, Russia and Puerto Rico, subject to completion of additional regulatory approvals (further details will be made available at http://www.clinicaltrials.gov).
In 2013, Ferrer successfully completed a first phase III clinical trial of Ozenoxacin in adult and paediatric patients aged two years and over with impetigo. The study demonstrated the superiority of Ozenoxacin one per cent cream versus a placebo, applied topically twice daily for five days, on both the clinical and bacteriological endpoints by end of therapy visit.
In addition, Ozenoxacin demonstrated a superior bacteriological cure compared to placebo by the second visit (day three-four). The trial also demonstrated that Ozenoxacin is safe and very well tolerated in the adult and paediatric populations.
“Impetigo due to bacterial skin infections remains a common problem, especially in infants and young children,” said Fernando Garcia Alonso, chief scientific officer at Ferrer. “The emergence of treatment resistant bacterial pathogens underpins the need for alternative agents such as Ozenoxacin. The clinical studies with Ozenoxacin performed by Ferrer aim to provide infants and others with impetigo an alternative, safe and effective topical antibacterial treatment. In addition, Ozenoxacin could represent a topical treatment for a broad range of other infectious dermatological conditions.”
The product is available for licensing worldwide from Ferrer, except in China, Japan, Korea, Taiwan, USA, Puerto Rico and US Virgin Islands.