Böttger E, Koch E, Tronnier H
Berufsdermatosen. 1977 Apr;25(2):53-62.
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.
外用皮质类固醇抗炎活性的临床试验 在9名无病理性皮肤改变但已知对金属离子（铬和镍）敏感的受试者中，测试了4种含皮质激素制剂和3种不含类固醇基质对皮肤温度的影响。将制剂在作用2小时和6小时后对健康皮肤的作用（血管收缩作用）与随后用接触性变应原处理24小时的皮肤部位的作用进行比较。在所采用的程序中，试验制剂在封闭敷料下作用2小时和6小时，或作用4小时和8小时，每种情况下敷料去除2小时。致敏导致皮肤表面温度升高，试验制剂对其有不同程度的影响。虽然在健康皮肤上未发现各糖皮质激素局部用药效果有统计学显著差异，但在评估对病理性皮肤过程的总体抗炎效果时，发现了一些明显的效果差异。比较结果时，获得了以下总体抗炎效果的降序排列：1. 0.1%醋酸氟泼尼立定，评分为4.5；2. 0.1%二氟可的龙戊酸酯，评分为8.5；3. 0.25%三甲基醋酸氟轻松+0.25%己酸氟轻松，评分为12；4. 0.1%去氧米松，评分为15。同时测试的不含类固醇基质对正常或炎症皮肤的温度未显示明显影响。所描述的测试程序结果具有可重复性，可用统计方法进行评估；因此该方法似乎适用于含类固醇局部用药的比较研究。该程序的特殊价值在于有可能在与炎性皮肤病患者使用直接相关的标准化炎症模型中直接测试制剂的效果，并以此确定哪些制剂获得的抗炎效果超过所有类固醇共有的一般效果。
