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 < .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.
Disclosure statement
The authors declare that they do not have conflict of interests.
Data availability statement
The data supporting the results can be obtained by request to the correspondent author.