Application of the Minolta Chromameter to the Assessment of Corticosteroid-lnduced Skin Blanching

  • Roderick B. Walker
  • John M. Haigh
  • Eric W. Smith


Technological advances in both analytical methodology and statistical analysis have refined the science of bioequivalence testing. In recent years, the design, performance, and evaluation of bioequivalence studies have received much attention from the industry, academia, and, more recently, from regulatory agencies. The drug delivery field that has possibly received the least attention in this regard is the bioequivalence assessment of topical formulations. Corticosteroids, especially, have been evaluated for several decades using a visual grading system for subjectively recording the intensity of the drug-induced vasoconstriction. As an alternative, a number of researchers (Pershing et al., 1992; Waring et al., 1993; Clarys et al., 1995) have used a Minolta chromameter to assess skin color following the application of cortico-steroid-containing formulations. Some years ago the Food and Drug Administration (FDA) proposed that a chromameter be used to measure blanching intensity when assessing topical corticosteroid activity for bioequivalence purposes (FDA, 1995). With this instrument it is theoretically possible to measure the intensity of skin-blanching as an absolute color, based on the tristimulus analysis of a reflected xenon light pulse. The result is expressed as a three-dimensional coordinate consisting of two color coordinates (the green-red or a-scale and the yellow-blue or b-scale) and a luminance coordinate (black-white or L-scale). These three coordinates (a, b,and L) should define the absolute color of a skin site at each Observation time as the vasoconstriction phenomenon varies


Topical Corticosteroid Application Site Product Application Betamethasone Dipropionate Bioequivalence Testing 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.


  1. Barry, B. W., and Woodford, R., 1978, Activity and bioavailability of topical steroids: In vivo/in vitro correlations for the vaso-constrictor test, J. Clin. Pharm. 3:43-65Google Scholar
  2. Clarys, P., Wets, L., Barel, A., and Gabard, B., 1995, The skin blanching assay with halcinolide, influence of halcinolide concentration and application time, J. Eur. Acad. Dermatol. Venereol. 5:250-257Google Scholar
  3. Demana, P. H., Smith, E. W., Walker, R. B., Haigh, J. M., and Kanfer, I., 1997, Evaluation of the proposed FDA pilot dose-response methodology for topical corticosteroid bioequivalence testing, Pharm. Res. 14:303-308PubMedCrossRefGoogle Scholar
  4. FDA, 1995, Guidance: Topical dermatologic corticosteroids: in vivo bioequivalence, Division of Bioequivalence, Office of Generic Drugs, Food and Drug Administration, Rockville, MD., June 1995Google Scholar
  5. Feldmann, R. J., and Maibach, H. I., 1965, Penetration of 14C-hydrocortisone through normal skin, Arch. Dermatol., 91:661-666PubMedCrossRefGoogle Scholar
  6. Haigh, J. M., and Kanfer, I., 1984, Assessment of topical corticosteroid preparations: the human skin blanching assay, Int. J. Pharm., 19:245-262CrossRefGoogle Scholar
  7. Haigh, J. M., Meyer, E., Smith, E. W., and Kanfer, I., 1997a, The human skin blanching assay for in vivo topical corticosteroid assessment: I. Reproducibility of the assay, Int. J. Pharm. 152:179-183CrossRefGoogle Scholar
  8. Haigh, J. M., Meyer, E., Smith, E. W., and Kanfer, I., 1997b, The human skin blanching assay for in vivo topical corticosteroid assessment: II. Subject- and observer-dependent variation in blanching responses, Int. J. Pharm. 152:185-192CrossRefGoogle Scholar
  9. Hunter, R. S., and Harold, R. W., 1987, The Measurement of Appearance, 2nd Ed., Wiley-Interscience, NewYorkGoogle Scholar
  10. Magnus, A. D., Haigh, J. M., and Kanfer, I., 1980, Assessment of some variables affecting the blanching activity of betamethasone 17-valerate cream, Dermatologica 160:321-327PubMedCrossRefGoogle Scholar
  11. Pershing, L. K., Lambert, L. D., Shah, V. P., and Lam, S. Y., 1992, Variability and correlation of chromameter and tape-stripping methods with the visual blanching assay in the quantitative assessment of topical 0.05% betamethasone dipropionate bioavailability in humans, Int. J. Pharm. 86:201-210CrossRefGoogle Scholar
  12. Smith, E. W., Meyer, E., Haigh, J. M., and Maibach, H. I., 1989, The human skin blanching assay as an indicator of topical corticosteroid bioavailability and potency: An update, in: Percutaneous Absorption, Vol. 2 (R. L. Bronaugh and H. I. Maibach, eds.) Marcel Dekker, New York, pp. 443-460Google Scholar
  13. Smith, E. W., Meyer, E., and Haigh, J. M., 1990, Blanching activities of betamethasone formulations: The effect of dosage form on topical drug availability, Drug Res. 40:618-621Google Scholar
  14. Smith, E. W., Meyer, E., Haigh, J. M., and Maibach, H. I., 1991, The human skin blanching assay for comparing topical corticosteroid availability, J. Dermatol. Treat. 2:69-72CrossRefGoogle Scholar
  15. Smith, E. W., Meyer, E., and Haigh, J. M., 1992, Accuracy and reproducibility of the multiple-reading skin blanching assay, in: Topical Corticosteroids (H. I. Maibach and C. Surber, eds.), Karger, Basel, pp. 65-73Google Scholar
  16. Smith, E. W., Haigh, J. M., and Walker, R. B., 1998, Analysis of chromameter results obtained from corticosteroid-induced skin blanching: I. Manipulation of data. Pharm. Res. 15:280-285PubMedCrossRefGoogle Scholar
  17. Waring, M. J., Monger, L., Hollingsbee, D. A., Martin, G. P., and Marriott, C., 1993, Assessment of corticosteroid-induced skin blanching: evaluation of the Minolta Chromameter CR200, Int. J. Pharm. 94:211-222CrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media New York 2000

Authors and Affiliations

  • Roderick B. Walker
    • 1
  • John M. Haigh
    • 1
  • Eric W. Smith
    • 1
  1. 1.Faculty of PharmacyRhodes UniversityGrahamstownSouth Africa

Personalised recommendations