Mj. Waring et al., ASSESSMENT OF CORTICOSTEROID-INDUCED SKIN BLANCHING - EVALUATION OF THE MINOLTA CHROMAMETER CR200, International journal of pharmaceutics, 94(1-3), 1993, pp. 211-222
The major criticism of the human bioassay currently employed for corti
costeroid activity is that it requires the use of experienced assessor
s subjectively to determine and rank the degree of skin pallor (blanch
ing) induced in the skin by the topical application of a formulated pr
oduct. Recently a number of studies have suggested that the use of tri
-stimulus colorimetry (using the Minolta Chromameter CR 200) provides
an instrumental and hence objective means of assessing such topical bl
anching activity. The aim of the present study was to evaluate further
the possibility of employing the Chromameter routinely in the bioassa
y of topical corticosteroids. In one study, employing ten volunteers,
the effects of pressure of the measuring device on the skin and the in
fluence of site of application were determined, prior to the applicati
on of any active agent. Blanching profiles were determined for clobeta
sol propionate (0.05%) and betamethasone 0.1% (as valerate) creams und
er occluded and unoccluded conditions (in a further two studies, each
comprising 10 volunteers) using both visual assessment and instrumenta
l measurement. It was established that: (1) application of pressure to
the skin induces a measurable change in skin colour and must be avoid
ed to prevent error in instrumental readings, (2) there is a variation
in natural skin colour from elbow to wrist, (3) there is a marked but
reproducible diurnal variation in skin colour, (4) providing the diur
nal variation in skin colour is subtracted from the readings obtained
as a result of corticosteroid-induced blanching, then a good correlati
on exists between the visual and chromameter techniques both for very
potent and potent corticosteroids. On the basis of these results, it i
s recommended that the use of the Chromameter in skin-blanching assays
still requires careful development and more validation before its use
can be recommended in a bioassay intended to replace the traditional
visual assessment method.