[Clinico-experimental testing for anti-inflammatory activity of external corticosteroids].

Abstract

Clinical trials of the anti-inflammatory activity of corticosteroids for external use The influence on skin temperature of 4 corticoid-containing formulations and 3 steroid-free bases was tested in 9 subjects in whom no pathological skin changes were present but who were known to be sensitive to metal ions (chromium and nickel). The effect of the preparations on the healthy skin (vasoconstrictive effect) after a duration of action of 2 and 6 h was compared with the effect on skin sites treated subsequently with the contact allergens for a period of 24 h. In the procedure used the trial preparations were allowed to act for 2 and 6 h under occlusive dressing, or for 4 and 8 h, the dressing being removed for 2 h in each case. The allergization produced an increase in temperature at the skin surface which was influenced in various ways by the trial preparations. Whereas no statistically significant differences in the effect of the individual steroid topicals were found the healthy skin, in the evaluatin of the overall anti-inflammatory effect on the pathological skin processes, some distinct differences in effect were found. On comparing the results the following lowing order was obtained for the overall anti-inflammatory effect: 1. Fluprednylidene acetate 0.1% score 4.5, 2. Difluocortolone-valerate 0.1% score 8.5, 3. Fluocortolone trimethylacetate 0.25% + fluocortolone caproate 0.25% score 12, 4. Desoxymethasone 0.1% score 15, The steroid-free bases tested simultaneously did not exhibit clear effects on the temperature in the normal or inflamed skin. The results of the test procedure described are reproducible and can be evaluated by statistical method; the method thus seems appropriate for comparative studies of steroid-containing topicals. The special value in the procedure is the possibility of testing the effect of the preparations directly in a standardised inflammation model which is directly related to use in patients with inflammatory skin diseases, and of establishing in this way in which preparations the anti-inflammatory effect obtained exceeds the general effect common to all steroids.