Molluscum Contagiosum Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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