Aly R, Maibach H I, Bagatell F K, Dittmar W, Hänel H, Falanga V, Leyden J J, Roth H L, Stoughton R B, Willis I
Department of Dermatology, University of California School of Medicine, San Francisco.
Clin Ther. 1989 May-Jun;11(3):290-303.
Studies were conducted to assess the bioequivalence of a new antimycotic formulation, ciclopirox olamine lotion 1%, to an established compound, ciclopirox olamine cream 1%. Results of in vitro studies, using skin samples from human cadavers and domestic pigs, demonstrated that the two formulations equally penetrate all layers of the stratum corneum and inhibit the growth of Trichophyton mentagrophytes and Candida albicans. In vivo studies in guinea pigs and in human volunteers demonstrated the comparable therapeutic efficacy of the lotion and the cream in experimental trichophytosis. In addition, a multicenter, double-blind clinical trial was undertaken to compare ciclopirox olamine lotion 1% with the vehicle alone in the treatment of patients with tinea pedis. Patients with plantar, interdigital, or vesicular tinea pedis were enrolled in the studies. Patients were treated for 28 days. Clinical and mycological responses were determined during treatment and two weeks posttreatment. Ciclopirox olamine lotion 1% was found to be significantly more effective than its vehicle in the treatment of patients with common tinea pedis. Minor localized side effects (pruritus, burning sensation) were reported in 2% of 89 patients treated with ciclopirox olamine lotion 1%. The results demonstrate the bioequivalence of ciclopirox olamine lotion 1% and ciclopirox olamine cream 1% and confirm the clinical effectiveness and safety of the lotion in the treatment of tinea pedis, a generally recalcitrant fungal infection. It is concluded that ciclopirox olamine lotion 1% can be used as an alternative to ciclopirox olamine cream 1% for treatment of tinea pedis, tinea versicolor, tinea cruris, tinea corporis, and cutaneous candidiasis when the convenience and/or cosmetic elegance of a lotion is desired.
开展了多项研究，以评估一种新型抗真菌制剂（1%环吡酮胺洗剂）与一种已上市的制剂（1%环吡酮胺乳膏）的生物等效性。使用来自人类尸体和家猪的皮肤样本进行的体外研究结果表明，这两种制剂对角质层各层的渗透能力相同，并能抑制须癣毛癣菌和白色念珠菌的生长。在豚鼠和人类志愿者身上进行的体内研究表明，该洗剂和乳膏在实验性癣病中具有相当的治疗效果。此外，还进行了一项多中心、双盲临床试验，比较1%环吡酮胺洗剂与单独使用赋形剂治疗足癣患者的效果。纳入研究的患者为足底、指间或水疱型足癣患者。患者接受治疗28天。在治疗期间和治疗后两周测定临床和真菌学反应。结果发现，1%环吡酮胺洗剂在治疗常见足癣患者方面明显比其赋形剂更有效。在接受1%环吡酮胺洗剂治疗的89名患者中，有2%报告出现轻微的局部副作用（瘙痒、烧灼感）。这些结果证明了1%环吡酮胺洗剂和1%环吡酮胺乳膏的生物等效性，并证实了该洗剂在治疗足癣（一种通常难以治愈的真菌感染）方面的临床有效性和安全性。得出的结论是，当需要洗剂的便利性和/或美观性时，1%环吡酮胺洗剂可作为1%环吡酮胺乳膏的替代品，用于治疗足癣、花斑癣、股癣、体癣和皮肤念珠菌病。
