Hamm Henning, Beiteke Ulrike, Höger Peter H, Seitz Cornelia S, Thaci Diamant, Sunderkötter Cord
Department of Dermatology, University of Würzburg, Würzburg, Germany.
J Dtsch Dermatol Ges. 2006 May;4(5):407-13. doi: 10.1111/j.1610-0387.2006.05941.x.
Until recently, no prescription drug containing permethrin for the therapy of scabies was available on the German market.Therefore, a 5% permethrin cream formulation (InfectoScab 5%) was tested in a single-arm multi-center study including adults and children from 3 months of age with proven scabies.
On day 0, patients were treated once with permethrin cream in the study center. Control examinations including dermatoscopy were performed on day 14+/-2 and on day 28+/-3. Patients who were not considered cured or who had contact to individuals with untreated scabies received one further treatment with permethrin cream on day 14+/-2. Itching and local tolerability of the cream were documented in patients' diaries. Side effects were assessed by history, skin inspection and evaluation of patients' notes.
106 patients in 13 centers were enrolled in the study. Their mean age was 29.2 years (range, 141 days to 71.9 years); 34% of them were children or adolescents. 78.3% of patients were either severely (3 body sites) or very severely (4-5 sites) affected. The cure rate on day 28+/-3 was 95.1% (95% confidence interval, 91.0-99.3%). Pruritus declined markedly and continuously. In general, the cream was well tolerated; side effects were almost invariably mild.
Our results support the efficacy and safety of 5% permethrin cream in adults, children and infants suffering from scabies. These results have contributed to the approval of InfectoScab 5% in Germany for the treatment of scabies in October 2004.
直到最近，德国市场上还没有含氯菊酯的治疗疥疮的处方药。因此，在一项单组多中心研究中对一种5%氯菊酯乳膏制剂（InfectoScab 5%）进行了测试，该研究纳入了3个月及以上确诊患有疥疮的成人和儿童。
在第0天，患者在研究中心接受一次氯菊酯乳膏治疗。在第14±2天和第28±3天进行包括皮肤镜检查在内的对照检查。未被视为治愈或与未治疗疥疮患者有接触的患者在第14±2天接受一次氯菊酯乳膏的进一步治疗。患者日记中记录了乳膏的瘙痒情况和局部耐受性。通过病史、皮肤检查和患者记录评估副作用。
13个中心的106名患者参与了该研究。他们的平均年龄为29.2岁（范围为141天至71.9岁）；其中34%为儿童或青少年。78.3%的患者受到严重（3个身体部位）或非常严重（4 - 5个部位）的影响。在第28±3天的治愈率为95.1%（95%置信区间，91.0 - 99.3%）。瘙痒明显且持续下降。总体而言，该乳膏耐受性良好；副作用几乎均为轻度。
我们的结果支持5%氯菊酯乳膏在患有疥疮的成人、儿童和婴儿中的有效性和安全性。这些结果促成了InfectoScab 5%于2004年10月在德国获批用于治疗疥疮。
