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Efficacy and Tolerance of the Topical Application of Potassium Hydroxide (10% and 15%) in the Treatment of Molluscum Contagiosum
BACKGROUND: Molluscum contagiosum is a non-serious children viral infection. Because of its natural history, being highly contagious and the aesthetic and psychotherapeutic effects of its treatment, the investigators intend to test the use of different concentrations of potassium hydroxide solution in the primary care setting. METHODS: A double blind, randomized clinical trial, in three groups of topic treatment is designed. The intended treatment consists on a daily application of potassium hydroxide in aqueous solution at 10% and 15% concentration, versus a placebo administered to the control group. 4 follow-up visits (15, 30, 45 and 60 days) are planned to evaluate treatment effectiveness and tolerance. The main target of the trial is to determine the healing rate, defined as lesion disappearance in the affected zones after the topic application of the treatment. Secondary targets are the main characteristics and evolution of the affected zone (surface, number of lesions, size and density) description, tolerance evaluation (hyperpigmentation, itching, burning, pain), recurrence rate estimation and natural evolution of lesions in the control group.
Age
2 - 6 years
Sex
ALL
Healthy Volunteers
No
CAP Rambla Ferran
Lleida, Catalonia, Spain
Start Date
March 1, 2010
Primary Completion Date
March 1, 2012
Completion Date
March 1, 2012
Last Updated
October 1, 2015
53
ACTUAL participants
Hydroxide Potassium
DRUG
Placebo
DRUG
Lead Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
NCT05937672
NCT05536882
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT05634460