Key Words

Visual ranking W Chromameter W Digital imaging 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 quan-tifying the vasoconstriction side-effect that follows corti-costeroid application to the skin. Although the chro-mameter 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 pre-liminary 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 eval-uation of objective assessment techniques, such as dig-ital imaging, and continued modernisation of regulatory bioequivalence requirements will assist in protecting pa-tients and optimising clinical results. Copyright © 2002 S. Karger AG, Base