A randomized, open-label, comparative clinical study for the evaluation of safety, tolerability and analgesic efficacy of two different presentations of topical medication in the treatment of dermatological curettage of molluscum contagiosum in pediatric patients

Submitted by Vitor Silverio Rodrigues (vitorsrodrigues@reitoria.unesp.br) on 2014-05-27T11:24:42Z No. of bitstreams: 0 Made available in DSpace on 2014-05-27T11:24:42Z (GMT). No. of bitstreams: 0 Previous issue date: 2010-06-01 Aim: This study aimed to compare the safety and analgesic efficacy of a new topical drug (in two different presentations: cream and aerosol) consisting of benzocaine, menthol and triclosan, in the curettage of molluscum contagiosum. Method: The study included 296 volunteers in different stages: 256 healthy adult volunteers for the safety evaluation, and 40 volunteers between 2 and 12 years old who presented Molluscum contagiosum, for the evaluation of tolerability and efficacy. Each volunteer represented two experimental units (left and right) where it was applied randomly the tested products (cream or aerosol) 30 minutes before the dermatological curettage, immediately after and twice a day during 7 days. Dermatological evaluations of safety and efficacy were performed immediately after the procedure, 3 and 7 days after the curettage. Results: During safety evaluation, the tested products showed no irritant, sensitizing, phototoxic or photosensitizing potential. Both presentations, cream and aerosol, were considered safe with no statistically significant differences between them. With respect to analgesic efficacy, the results showed that the medication promoted the reduction of painful symptoms and there was no statistically significant difference (p