Pigatto P, Colli E, Scatigna M, Finzi A
2nd Department of Dermatology, University of Milan, Italy.
Arzneimittelforschung. 1990 Mar;40(3):329-31.
A double blind, randomized clinical trial was performed on twelve healthy volunteers to evaluate the irritation potential of fenticonazole 2% cream (Lomexin) and spray versus micomazole 2% cream and econazole 1% spray. The contact-sensitizing potential of the two fenticonazole preparations was also investigated. There was no evidence of irritation after the treatments with fenticonazole cream, its excipients, miconazole cream and fenticonazole spray excipients, whereas signs of irritation were observed in four cases after treatment with the spray formulations (two after fenticonazole, two after econazole). The contact-sensitizing test was performed only with fenticonazole 2% cream and spray. Neither spray nor cream formulation of fenticonazole showed evidence of sensitization in any of the twelve subjects.
对12名健康志愿者进行了一项双盲随机临床试验,以评估2%联苯苄唑乳膏(洛美新)和喷雾剂与2%咪康唑乳膏及1%益康唑喷雾剂相比的刺激可能性。还研究了两种联苯苄唑制剂的接触致敏可能性。使用联苯苄唑乳膏、其辅料、咪康唑乳膏及联苯苄唑喷雾剂辅料进行治疗后,均未出现刺激迹象,而使用喷雾剂制剂治疗后,有4例出现刺激迹象(2例使用联苯苄唑后,2例使用益康唑后)。仅对联苯苄唑2%乳膏和喷雾剂进行了接触致敏试验。在12名受试者中,联苯苄唑的喷雾剂和乳膏制剂均未显示出致敏迹象。