Reygagne Pascal, Poncet Michel, Sidou Farzaneh, Soto Pascale
Galderma R&D, Sophia Antipolis, France.
Cutis. 2007 May;79(5):397-403.
Seborrheic dermatitis (SD), a common dermatosis associating hyperseborrhea, erythema, itching, and dandruff, has frequent scalp involvement. Malassezia furfur infection seems to play an important role in the condition's etiopathology. Treatment of SD usually consists of corticosteroids or antifungals, such as ketoconazole. The aim of this multicenter, randomized, investigator-blinded, parallel-group pilot study was to evaluate the efficacy and safety of clobetasol propionate shampoo 0.05% after different short-contact application times compared with its vehicle and ketoconazole foaming gel 2% in the treatment of SD of the scalp. For 4 weeks, 55 subjects received one of the following treatments twice weekly: clobetasol propionate shampoo for 2.5, 5, or 10 minutes; clobetasol propionate vehicle for 10 minutes; or ketoconazole foaming gel for 5 minutes before rinsing off. Efficacy criteria included total severity score (TSS) and individual scores of signs such as itching and global improvement. Safety included reporting of burning, overall tolerance, and adverse events. Results showed that an application of clobetasol propionate for 5 and 10 minutes provided a similar mean percentage decrease of TSS, and the mean percentage decrease of TSS for all active groups was significantly superior to that of the vehicle (P < .01). Overall and local safety were good for all treatment groups. The present pilot study demonstrated that a short-contact application of clobetasol propionate shampoo is effective and safe in the treatment of SD of the scalp.
脂溢性皮炎(SD)是一种常见的皮肤病,伴有皮脂溢出、红斑、瘙痒和头皮屑,常累及头皮。糠秕马拉色菌感染似乎在该病的病因病理中起重要作用。SD的治疗通常包括使用皮质类固醇或抗真菌药物,如酮康唑。这项多中心、随机、研究者盲法、平行组的试点研究旨在评估0.05%丙酸氯倍他索洗发水在不同短时间接触应用后的疗效和安全性,并与赋形剂和2%酮康唑泡沫凝胶在治疗头皮SD方面进行比较。在4周内,55名受试者每周接受以下治疗之一两次:丙酸氯倍他索洗发水使用2.5、5或10分钟;丙酸氯倍他索赋形剂使用10分钟;或酮康唑泡沫凝胶使用5分钟后冲洗掉。疗效标准包括总严重程度评分(TSS)和瘙痒等体征的个体评分以及整体改善情况。安全性包括烧灼感报告、总体耐受性和不良事件。结果表明,使用丙酸氯倍他索5分钟和10分钟后,TSS的平均下降百分比相似,所有活性组的TSS平均下降百分比均显著优于赋形剂组(P <.01)。所有治疗组的总体和局部安全性良好。本试点研究表明,短时间接触应用丙酸氯倍他索洗发水治疗头皮SD是有效且安全的。