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Randomized Placebo-controlled Clinical Trial on Efficacy and Safety of Topical 10% Potassium Hydroxide for Molluscum Contagiosum Treatment in Children.

Research paper by Maria M Giner-Soriano, Concepció C Teixidó, Josep R JR Marsal, Olga O Díez, Helena H Pera, Bogdan B Vlacho, Rosa R Morros,

Indexed on: 23 Jan '19Published on: 23 Jan '19Published in: The Journal of dermatological treatment



Abstract

Introduction Our objective was to assess efficacy, safety and tolerance of topical potassium hydroxide (KOH) 10% for treating Molluscum contagiosum (MC) in children. Material and Methods Randomized, double-blind, placebo-controlled clinical trial including all children 2-16 years with MC infection attending pediatrician primary healthcare visits. The treatment was KOH 10% gel applied once daily up to clearing (maximum 30 days). Results KOH 10% showed superior efficacy to placebo (55.3% vs 16.3%, p < 0.001). Time until clearing was inferior with KOH 10% (p= 0.001). MC lesions were reduced with KOH 10%, which also showed higher efficacy when the instructions of use of the device were modified. KOH 10% patients presented more adverse events (AE) than placebo patients (72.3% vs 31.8%, p < 0.001). Most patients (91.5%) completely recovered. There were no differences in frequency of AE before and after the change of instructions, intolerance was more frequently reported by parents with new instructions. Conclusions KOH 10% was superior to placebo in the main efficacy outcome and most secondary efficacy outcomes. KOH 10% patients had more AE and intolerance symptoms than placebo, although there were no severe AE and most patients recovered. KOH 10% is an effective and safe topical treatment for MC infection in children.