To date, human skin phototype (SPT) has been determined subjectively by self- or trained investigator assessment using sun burning and/or sun tanning responses, ethnicity, hair, and eye color. This study evaluated objective reflectance spectrophotometer (RS) assessment of SPT in 353 males or females (18-72 years old with Fitzpatrick SPT I-VI) using the area-under-the-intensity curve (AUIC) over the 450-615 nm wavelength interval of reflected light (AUIC). Photoprotected constitutive skin color sites produced higher AUIC values than photo-exposed facultative skin color sites. Constitutive skin color at the upper volar arm was equal to the buttocks. Within-site and between-site AUIC reproducibility of constitutive skin color at the upper volar arm was 3 and 5% coefficient of variation (CV), respectively, which was similar to seasonal variability (8% CV). AUIC values decreased proportionately at both constitutive and facultative sites as a function of increasing SPT from I to VI (r=0.8). RS-measured constitutive skin color at the upper volar arm fit a quadratic equation (r(2)=0.94) that differentiated (P<0.05) between each of the six SPTs and agreed +/-1 SPT category with clinician-assessed SPT. Thus, RS assessment of constitutive skin color at the upper volar arm provides a quick, noninvasive, precise, and accurate method to objectively determine SPT.

The dermatopharmacokinetic method allowed simultaneous evaluation of both products in the same subject, within the same study period, and was more sensitive and discriminating in the assessment of bioequivalence between the two miconazole nitrate vaginal cream, 2% products than the clinical trial method.

Disposition and uptake/elimination profiles of topical 2,6-di-t-butyl, 4-nitrophenol (DBNP), the nitrated metabolite of an antioxidant additive of lubricant and hydraulic fluids was quantified in human skin grafted on athymic mice after a single topical 75 microg dose in corn oil. DBNP was quantified throughout the stratum corneum (SC), epidermis (E) and dermis (D) in punch biopsies collected from treated skin 0.5, 1, 2, 4, 8 and 24 h after application. SC samples were harvested from the treated skin with 20 adhesive discs. E and D were generated from the biopsy using a manual sectioning method. Detectable DBNP concentrations were measured in all skin compartments at all time points investigated. The Cmax of DBNP in SC was 1663 +/- 602 microg cm(-3), and approximately 30 and approximately 300 fold greater than the Cmax for E and D, respectively. Tmax occurred at 1.0, 0.5 and 1.0 in the SC, E and D, respectively. Over a 24 h interval (AUC0-24 h) there was 52 and 520 fold more DBNP in the SC than E and D, respectively. The elimination half-life of DBNP was 11 h from the SC and 9 h from both E and D. Thus, DBNP was quickly absorbed into the outermost layer of skin and established a steep concentration profile through human skin. The data are consistent with the vast majority of DBNP remaining on the surface (77%) or within human skin (15%) in vivo with only 0.2% of the DBNP dose quantified in the systemic blood circulation.