Clinical Trial: Efficacy and Tolerance of Potassium Hydroxide (10% and 15%) in Molluscum Contagiosum

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy and Tolerance of the Topical Application of Potassium Hydroxide (10% and 15%) in the Treatment of Molluscum Contagiosum

Brief Summary:

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.

Detailed Summary:
Sponsor: Jordi Gol i Gurina Foundation

Current Primary Outcome: Efficacy (diseappearance of lesions) [ Time Frame: 60 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Jordi Gol i Gurina Foundation

Dates:
Date Received: May 4, 2011
Date Started: March 2010
Date Completion:
Last Updated: September 30, 2015
Last Verified: May 2011