Centre de Pharmacologie Clinique Appliquée à la Dermatologie, Hôpital de l'Archet 2, Nice, France.
Clin Drug Investig. 2012 Sep 1;32(9):613-9. doi: 10.1007/BF03261916.
In 1972, Dumas and Scholtz developed the psoriasis plaque test to evaluate the potency of local corticosteroids. Through further modification of this method, the efficacy between antipsoriatic products can be differentiated. This method allowed for the simultaneous application of several products to different test sites in the same psoriasis patient. The objective of this current study was to compare the antipsoriatic effect of six topical products using a modified version of the original psoriasis plaque test with emphasis on the predictive capacity of this model. Validation of the use of immunohistochemical and histological scoring of biopsy material, in conjunction with clinical scoring, in the prediction of antipsoriatic effects was an additional objective.
This study was a single-centre, investigator-blinded, within-subject randomized, active- and vehicle-controlled, intraindividual comparison of six topical products in patients with psoriasis vulgaris. The products evaluated were calcipotriol ointment (50 μg/g); calcipotriol cream (50 μg/g); two-compound ointment (calcipotriol 50 μg/g; betamethasone dipropionate 0.5 mg/g); two-compound gel (calcipotriol 50 μg/g; betamethasone dipropionate 0.5 mg/g) [all in their marketed formulations]; an investigational ointment (calcipotriol 25 μg/g; hydrocortisone 10 mg/g); and a vehicle control. Psoriasis patients (≥18 years of age; n = 24) received simultaneous topical application of each of the products 6 days a week for a period of 21 days, at different test sites located on psoriasis plaques. Clinical assessment of the test sites was completed twice a week. Test site biopsies were taken at the final visit for histological analysis. The primary endpoint was the absolute change in total clinical score (TCS; erythema, scaling and infiltration) from baseline.
For all products, the change in TCS correlated well with changes in histological and immunohistochemical values. The two-compound ointment and the two-compound gel both resulted in a large and significant reduction in TCS. Calcipotriol ointment and the calcipotriol/hydrocortisone ointment were less effective, although they were still more effective than the calcipotriol cream and the ointment vehicle.
This study has demonstrated that the modified psoriasis plaque test can provide a relatively quick and effective method to evaluate the antipsoriatic effect of several topical treatments in small cohorts and that, by combining clinical scoring and histological assessment, a more accurate prediction of the antipsoriatic effect can be made. The two-compound formulations (ointment and gel) had a comparable antipsoriatic effect, which was superior to the other products tested. Furthermore, these data indicate that the gel formulation could provide an alternative effective treatment option to the well established two-compound ointment for psoriasis patients.
Registered as EudraCT no: 2007-005463-10.
1972 年，Dumas 和 Scholtz 开发了银屑病斑块试验来评估局部皮质类固醇的效力。通过对该方法的进一步改进，可以区分抗银屑病产品之间的疗效。这种方法允许在同一银屑病患者的不同测试部位同时应用几种产品。本研究的目的是使用改良的原始银屑病斑块试验比较六种局部产品的抗银屑病效果，并特别强调该模型的预测能力。验证免疫组织化学和组织学评分的使用，结合临床评分，预测抗银屑病效果是另一个目标。
这是一项单中心、研究者盲法、自身对照、随机、阳性药物和载体对照、个体内比较 24 例寻常型银屑病患者六种局部产品的研究。评估的产品为卡泊三醇软膏（50μg/g）；卡泊三醇乳膏（50μg/g）；复方软膏（卡泊三醇 50μg/g；倍他米松二丙酸酯 0.5mg/g）；复方凝胶（卡泊三醇 50μg/g；倍他米松二丙酸酯 0.5mg/g）[均为市售制剂]；一种研究用软膏（卡泊三醇 25μg/g；氢化可的松 10mg/g）；和载体对照。银屑病患者（≥18 岁；n=24）每周 6 天同时在不同的银屑病斑块测试部位使用每种产品进行局部应用，为期 21 天。每周两次完成测试部位的临床评估。在最后一次就诊时进行测试部位活检以进行组织学分析。主要终点是从基线开始总临床评分（TCS；红斑、鳞屑和浸润）的绝对变化。
对于所有产品，TCS 的变化与组织学和免疫组织化学值的变化密切相关。复方软膏和复方凝胶均导致 TCS 显著且大幅度降低。卡泊三醇软膏和卡泊三醇/氢化可的松软膏的效果较差，尽管它们仍比卡泊三醇乳膏和软膏载体更有效。
本研究表明，改良的银屑病斑块试验可以为小队列中几种局部治疗的抗银屑病效果提供一种相对快速有效的评估方法，并且通过结合临床评分和组织学评估，可以更准确地预测抗银屑病效果。两种复方制剂（软膏和凝胶）具有相似的抗银屑病作用，优于其他测试产品。此外，这些数据表明，对于银屑病患者，凝胶制剂可以为已建立的复方软膏提供一种有效的替代治疗选择。
在 EudraCT 注册编号：2007-005463-10。
