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 < .001). Time until clearing was inferior with KOH 10% (p = .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 < .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.
Keywords: Molluscum contagiosum; pediatrics; potassium hydroxide; randomized clinical trial.