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.

journal_name

Future Microbiol

journal_title

Future microbiology

authors

Gropper S,Albareda N,Santos B,Febbraro S

doi

10.2217/fmb.14.83

subject

Has Abstract

pub_date

2014-01-01 00:00:00

pages

S17-22

issue

8 Suppl

eissn

1746-0913

issn

1746-0921

journal_volume

9

pub_type

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