Quantification of corticosteroid-induced skin vasoconstriction: visual ranking, chromameter measurement or digital imaging analysis.
Topical corticosteroid formulations have been evaluated by visual grading protocols for many years. Toward a more objective methodology, several instrumental methods have been evaluated for applicability in quantifying the vasoconstriction side-effect that follows corticosteroid application to the skin. Although the chromameter has been adopted by regulatory bodies throughout the world as the current standard for topical bioequivalence determinations, there is considerable criticism of this instrument from several quarters. A preliminary comparison reported here indicates that digital image analysis provides statistically significant results that are similar to those obtained by visual assessment techniques, and shows considerably greater precision than that obtained by the chromameter. Continued evaluation of objective assessment techniques, such as digital imaging, and continued modernisation of regulatory bioequivalence requirements will assist in protecting patients and optimising clinical results.
Smith
E W
EW
College of Pharmacy, Ohio Northern University, Ada 45810, USA. e-smith3@onu.edu
Haigh
J M
JM
Surber
C
C
D000287:Administration, Topical; D000893:Anti-Inflammatory Agents / Q000494:pharmacology*; D003124:Colorimetry / Q000295:instrumentation; D005938:Glucocorticoids; D006801:Humans; D007091:Image Processing, Computer-Assisted; D014677:Pharmaceutical Vehicles; D012867:Skin / Q000098:blood supply*; D013810:Therapeutic Equivalency; D014661:Vasoconstriction / Q000187:drug effects*; D014796:Visual Perception
D000893:Anti-Inflammatory Agents; D005938:Glucocorticoids; D014677:Pharmaceutical Vehicles