Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD), Hôpital de l'Archet, Nice, France.
J Dermatolog Treat. 2013 Aug;24(4):250-4. doi: 10.3109/09546634.2011.641936. Epub 2011 Dec 21.
The efficacy and safety of calcipotriol plus betamethasone dipropionate ointment in the treatment of psoriasis vulgaris has consistently been demonstrated in several clinical trials. For treatment of scalp psoriasis, more convenient formulations are required. Therefore, new lipophilic alcohol-free gel formulations containing calcipotriol (50 µg/g) and betamethasone (0.5 mg/g; as dipropionate) (two-compound gels) for treatment of scalp psoriasis were developed.
To identify the optimal gel formulation by evaluating the antipsoriatic effect in a psoriasis plaque test model.
The use of a psoriasis plaque test enables investigation of the antipsoriatic effect of several formulations and compounds in a limited number of patients, and is a useful method for predicting treatment efficacy in psoriasis vulgaris. Five different gel vehicles were investigated in two plaque test studies.
The optimised two-compound gels showed superior antipsoriatic effect over marketed betamethasone dipropionate solution. The results suggest that use of the psoriasis plaque test early in the development process can improve the development of topical formulations for dermatological use and can be a beneficial tool for selecting the most promising formulations for further clinical studies in psoriasis vulgaris.
卡泊三醇倍他米松软膏在治疗寻常型银屑病方面的疗效和安全性已在多项临床试验中得到证实。为治疗头皮银屑病，需要更方便的制剂。因此，开发了新的亲脂性无酒精凝胶制剂，含有卡泊三醇（50μg/g）和倍他米松（0.5mg/g；双丙酸酯）（复方凝胶），用于治疗头皮银屑病。
通过在银屑病斑块试验模型中评估抗银屑病效果，确定最佳凝胶配方。
使用银屑病斑块试验可以在有限数量的患者中研究几种制剂和化合物的抗银屑病效果，是预测寻常型银屑病治疗效果的有用方法。在两项斑块试验研究中，考察了 5 种不同的凝胶载体。
优化的复方凝胶显示出比市售的倍他米松二丙酸酯溶液更好的抗银屑病效果。结果表明，在开发过程的早期使用银屑病斑块试验可以改善皮肤科用局部制剂的开发，并可以成为一种有益的工具，用于选择最有前途的制剂进行进一步的寻常型银屑病临床研究。
