1. 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
- Author
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Schalka, Sérgio, Addor, Flávia Alvim Sant'Anna, Silva, Vanessa de Melo [UNESP], Pinto, Patrícia Camarano [UNESP], Milan, Ana Lúcia Koff, Pannuti, Estela Maia Bellini [UNESP], Universidade de São Paulo (USP), UNISA, Medcin Instituto da Pele Ltda., Universidade Estadual Paulista (Unesp), Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), and Eurofarma Laboratórios Ltda.
- Subjects
Local anesthesia ,drug dosage form comparison ,drug safety ,triclosan ,side effect ,menthol ,Molluscum contagiosum ,preschool child ,Curettage ,phototoxicity ,open study ,skin irritation ,benzocaine ,drug mechanism ,controlled study ,skin sensitization ,human ,analgesic activity ,ef 028 ,child ,treatment duration ,controlled clinical trial ,childhood disease ,photosensitization ,clinical trial ,analgesic agent ,school child ,major clinical study ,unclassified drug ,drug efficacy ,drug formulation ,randomized controlled trial ,skin surgery ,benzocaine plus menthol plus triclosan ,postoperative pain ,drug tolerability - Abstract
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
- Published
- 2010