title: Skin tissue exposure of once- versus twice-daily topical ozenoxacin 2% cream: a Phase I study in healthy volunteers.
abstract: In this Phase I study, healthy volunteers (n = 24) were randomly allocated to receive either one or two 0.2-g applications per day (12 h apart) of ozenoxacin 2% cream on three different areas of the back for 3 consecutive days. Ozenoxacin concentrations were measured in tape stripping samples (from the stratum corneum) and in skin punch biopsy samples (from the epidermis and dermis) taken predose from selected dosing areas on study days 2, 3 and 4. Ozenoxacin concentrations were high in the stratum corneum and were approximately twofold greater for the twice- versus once-daily application. Ozenoxacin concentrations were low in the epidermis and were higher for the twice- versus once-daily application. Ozenoxacin concentrations in the dermis were below the limit of quantitation on most study days.
authors.affiliation: Ferrer Internacional SA, Av. Diagonal 549, 5th Floor, 08029 Barcelona, Spain.
authors.forename: Savion
authors.initials: S
authors.lastname: Gropper
authors.forename: Nuria
authors.initials: N
authors.lastname: Albareda
authors.forename: Benjamin
authors.initials: B
authors.lastname: Santos
authors.forename: Salvatore
authors.initials: S
authors.lastname: Febbraro
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000631:Aminopyridines / Q000008:administration & dosage*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D005260:Female; D064368:Healthy Volunteers; D006801:Humans; D008297:Male; D008875:Middle Aged; D015363:Quinolones / Q000008:administration & dosage*; D012867:Skin / Q000187:drug effects*; D055815:Young Adult
chemical_list: D000631:Aminopyridines; D000900:Anti-Bacterial Agents; D015363:Quinolones; C000592413:ozenoxacin
keywords: Phase I study; dermis; epidermis; ozenoxacin; stratum corneum; tolerability; topical antimicrobials; volunteers