title: Cumulative irritation, sensitizing potential, phototoxicity and photoallergy of ozenoxacin in healthy adult volunteers.
abstract: In this series of Phase I, randomized, placebo-controlled studies in healthy volunteers, the potential for ozenoxacin 1 and 2% cream formulations to cause irritation, sensitization, phototoxicity and photoallergy under occlusive patch conditions was evaluated. Both ozenoxacin formulations showed excellent dermal tolerability; in the vast majority of cases, only minimal signs of erythema were observed, with no evidence of edema or a papular response. No subject met the criteria for a phototoxic reaction with the ozenoxacin 1 or 2% cream formulations. Only a few adverse events were reported across repeated-dose studies, and virtually all events were considered to be unrelated or unlikely to be related to ozenoxacin application. Ozenoxacin was safe, well tolerated and showed little or no tendency to cause irritation, sensitization, phototoxicity or photoallergy.
authors.affiliation: Ferrer Internacional SA, Av. Diagonal 549, 5th Floor, 08029 Barcelona, Spain.
authors.forename: Savion
authors.initials: S
authors.lastname: Gropper
authors.forename: Ana Luisa
authors.initials: AL
authors.lastname: Cepero
authors.forename: Jonathan S
authors.initials: JS
authors.lastname: Dosik
authors.forename: Phillip
authors.initials: P
authors.lastname: LaStella
authors.forename: Heinrich
authors.initials: H
authors.lastname: Siemetzki
authors.forename: Walter
authors.initials: W
authors.lastname: Wigger-Alberti
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000631:Aminopyridines / Q000008:administration & dosage / Q000009:adverse effects* / Q000737:chemistry; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000737:chemistry; D004305:Dose-Response Relationship, Drug; D004355:Drug Stability; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015363:Quinolones / Q000008:administration & dosage / Q000009:adverse effects* / Q000737:chemistry; D012867:Skin / Q000187:drug effects* / Q000528:radiation effects; D014838:Volunteers; D055815:Young Adult
chemical_list: D000631:Aminopyridines; D000900:Anti-Bacterial Agents; D015363:Quinolones; C000592413:ozenoxacin
keywords: ozenoxacin; photoallergy; phototoxicity; skin irritation; skin sensitization; volunteers