The potencies of topical corticosteroid products have mainly been classified using clinical data but in some instances, the US Food and Drug Administration’s (FDA’s) vasoconstrictor assay (VCA) to assess the skin blanching response has also been used. However, the reported skin blanching response data were often based on a single visual reading and lack information on the dose (amount/quantity) or dose duration. Although several lists classifying potencies of various topical corticosteroid products have been published, the inherent potencies of topical corticosteroid raw materials used as active pharmaceutical ingredients (APIs) have not been investigated. The objective was to rank the inherent potencies of topical corticosteroid APIs and to standardize dosing such that the relevant compounds could be compared on a normalized molar basis. The potencies of clobetasol propionate, halcinonide, mometasone furoate, and fluocinolone acetonide were compared using the resulting E_max data following the fitting of the relevant response data to the E_max model where mometasone furoate > fluocinolone acetonide = clobetasol propionate > halcinonide. This ranking lists the respective inherent potencies of the APIs, which will facilitate the choice of a suitable candidate for incorporation into an appropriate topical corticosteroid product for a specific clinical indication.

中文翻译：

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一种评估外用皮质类固醇效力的新方法

外用皮质类固醇产品的效力主要根据临床数据进行分类，但在某些情况下，也使用了美国食品和药物管理局 (FDA) 的血管收缩试验 (VCA) 来评估皮肤变白反应。然而，报告的皮肤变白反应数据通常基于单一的视觉读数，并且缺乏有关剂量（数量/数量）或剂量持续时间的信息。尽管已经发布了几个分类各种外用皮质类固醇产品效力的列表，但尚未研究用作活性药物成分 (API) 的外用皮质类固醇原料的内在效力。目的是对局部皮质类固醇 API 的内在效力进行排序并标准化剂量，以便可以在标准化摩尔基础上比较相关化合物。将相关响应数据拟合到E _max模型后的E _max数据，其中糠酸莫米松 > 氟轻松 = 丙酸氯倍他索 > halcinonide。该排名列出了 API 各自的固有效力，这将有助于选择合适的候选药物，以将其纳入特定临床适应症的适当外用皮质类固醇产品中。