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 Marsal, Ines Cruz, Concepcio Teixido, Olga Diez, Mireia Martinez, Gisela Galindo, Jordi Real, Joan A Schoenenberger, Helena Pera, Josep R Marsal, Ines Cruz, Concepcio Teixido, Olga Diez, Mireia Martinez, Gisela Galindo, Jordi Real, Joan A Schoenenberger, Helena Pera

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.

References

    1. Lewis E, Lam M, Crutchfield CE. An update on molluscum contagiosum. Cutis. 1997;60:29–34.
    1. Hinostroza-da-Conceicao D, Beirana-Palencia A. Tratamiento del molusco contagioso con hidróxido de potasio al 15% en solución acuosa. Dermatol peru. 2004;14:184–189.
    1. López JL. Epidemiologia y estructura molecular del virus Molluscum contagiosum. Piel. 1998;3:6–8.
    1. Lowy D. In: Dermatology in General Medicine. Fitzpatick T, editor. McGraw-Hill. New York; 1997. Molluscum contagiosum; pp. 2478–81.
    1. Arenas R. Dermatología, atlas, diagnóstico y tratamiento. Mexico: McGraw-Hill Interamericana; 1997. pp. 548–9.
    1. Liota E, Smith KJ, Buckley R, Menon P, Skelton H. Imiquimod therapy for molluscum contagiosum. J Cutan Med Surg. 2000;4:76–82.
    1. Short KA, Fuller LC, Higgins EM. Ensayo clínico con asignación aleatorio, control doble ciego y control placebo sobre la aplicación tópica de una solución de hidróxido potásico al 10% en el tratamiento del molusco contagioso. Pediatr Dermatol. (Ed. Esp.) 2007;3(1):40–43.
    1. Romiti R, Ribeiro AP, Grinblat BM, Rivitti EA, Romiti N. Treatment of Molluscum Contagiosum with Potassium Hydroxide: A Clinical Approach in 35 Children. Ped Dermatol. 1999;16:228–31. doi: 10.1046/j.1525-1470.1999.00066.x.
    1. Mahajan BB, Pall A, Gupta RR. Topical 20% KOH - An effective therapeutic modality for moluscum contagiosum in children. Indian Journal of Dermatology, Venereology and Leprology (IJDVL) 2003;69(2):175–177.
    1. Barba A, Kapoor S, Berman B. An open label safety study of topical imiquimod 5% cream in the treatment of molluscum contagiosum in children. Dermatology Online Journal l. p. 20.

Source: PubMed

赞助者和合作者

医疗条件

药物干预

3
订阅