Randomized placebo-controlled clinical trial on efficacy and safety of topical 10% Potassium hydroxide for molluscum contagiosum treatment in children

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.

Keywords:

• Molluscum contagiosum
• potassium hydroxide
• randomized clinical trial
• pediatrics

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.

Additional information

Funding

The conduction of this randomized clinical trial has been funded by the Institut Universitari d’Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol).Reig Jofre only supplied the treatments. They did not participate in the design, the execution of the clinical trial, the statistical analysis, the results interpretation or the writing and review of the manuscript.