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


CONCLUSIONS
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).
Primary Care Research Institute IDIAP Jordi Gol, Catalan Institute of Health, Rambla de Ferran, 44, 3ª, Lleida, Spain.
Josep R
JR
Marsal
Ines
I
Cruz
Concepcio
C
Teixido
Olga
O
Diez
Mireia
M
Martinez
Gisela
G
Galindo
Jordi
J
Real
Joan A
JA
Schoenenberger
Helena
H
Pera
D000287:Administration, Topical; D000891:Anti-Infective Agents, Local / Q000008:administration & dosage* / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D002985:Clinical Protocols; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D006801:Humans; D006878:Hydroxides / Q000008:administration & dosage* / Q000009:adverse effects*; D008976:Molluscum Contagiosum / Q000188:drug therapy* / Q000473:pathology; D010919:Placebos / Q000008:administration & dosage; D017680:Potassium Compounds / Q000008:administration & dosage* / Q000009:adverse effects*; D016896:Treatment Outcome
D000891:Anti-Infective Agents, Local; D006878:Hydroxides; D010919:Placebos; D017680:Potassium Compounds; C029943:potassium hydroxide