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Open Access Highly Accessed Study protocol

Efficacy and tolerance of the topical application of potassium hydroxide (10% and 15%) in the treatment of molluscum contagiosum: Randomized clinical trial: Research protocol

Josep R Marsal1, Ines Cruz12*, Concepcio Teixido3, Olga Diez3, Mireia Martinez4, Gisela Galindo12, Jordi Real1, Joan A Schoenenberger4 and Helena Pera5

Author Affiliations

1 Primary Care Research Institute IDIAP Jordi Gol, Catalan Institute of Health. Rambla de Ferran, 44, 3ª. Lleida, Spain

2 Ronda Health Center, Catalan Institute of Health. C/de la Mercè, 5. Lleida, Spain

3 Rambla de Ferran Health Center, Catalan Institute of Health. Rambla de Ferran, 44. Lleida, Spain

4 University Hospital Arnau de Vilanova. Pharmacy Unit. Institut de Recerca Biomèdica de Lleida. Alcalde Rovira Roure, 80. Lleida. Spain

5 Primary Care Research Institute IDIAP Jordi Gol, Catalan Institute of Health. Gran Via de les Corts Catalanes, 587, àtic. Barcelona. Spain

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BMC Infectious Diseases 2011, 11:278  doi:10.1186/1471-2334-11-278

Published: 19 October 2011

Abstract

Background

Molluscum contagiosum is a non-severe pediatric viral infection. Because it is highly contagious and current treatments have negative aesthetic and psychological effects, we want to test an alternative treatment in the primary care setting, consisting of two different concentrations of potassium hydroxide solution.

Methods/design

The study design is a double-blind, randomized clinical trial, using three types of topical treatment. The treatment consist of daily applications of potassium hydroxide (KOH) in aqueous solution at 10% and 15% concentration, and a placebo administered in the control group. Four follow-up visits (at 15, 30, 45 and 60 days) are planned to evaluate treatment effectiveness and patient tolerance.

The main outcome measure of the trial will be the healing rate, defined as lesion disappearance in the affected zones after the topic application of the experimental treatment. Secondary measures will be the principal characteristics and evolution of the affected zone (surface area, number of lesions, size and density of lesions), treatment tolerance (hyperpigmentation, itching, burning, pain), recurrence rate and the natural evolution of lesions in the control group.

Discussion

KOH can potentially be an effective and safe treatment for MC in primary care, and can also reduce referrals to dermatologists and hospital pediatric departments. In addition, KOH may be a valid and less expensive alternative to current invasive treatments (surgical excision).

Trial Registration

ClinicalTrials.gov: NCT01348386