Systemic bioavailability, safety and tolerability of topical ozenoxacin in healthy adult volunteers. (August 2014)

• Record Type: Journal Article
• Authors: Gropper, Savion; Albareda, Nuria; Santos, Benjamin; Febbraro, Salvatore
• Is Part Of: Future microbiology. Volume 9(2014)Supplement 8
• Page Start: S11
• Page End: S16
• Publication Date: 2014-08
• Subjects: healthy volunteers -- ozenoxacin -- Phase I studies -- safety -- tolerability; Microbiology -- Research -- Periodicals; 616.9041
• DOI: 10.2217/fmb.14.82
• Languages: English
• ISSNs: 1746-0913

Abstract

ABSTRACT: : A series of Phase I studies was conducted in healthy volunteers to examine the systemic bioavailability and safety of topical ozenoxacin. Study 1 examined increasing single doses (relating to quantity and body surface area) of ozenoxacin 1% ointment. Study 2 compared multiple doses of ozenoxacin 1% ointment and placebo applied for 7 days. Study 3 investigated multiple doses of ozenoxacin 2% cream and placebo applied for 7 days. Study 4 examined multiple doses of ozenoxacin 2% cream applied to intact and abraded skin for 8 days. No systemic absorption was observed in any study and ozenoxacin was well tolerated. The most common treatment-related adverse events were application-site reactions (erythema and pruritus), but the differences in local tolerability between ozenoxacin and placebo were not clinically significant.