NCT01348386

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina · Academic / Other
• Sex: All
• Age: 2 Years – 6 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Molluscum Contagiosum

Interventions

Type	Name	Description
DRUG	Hydroxide Potassium	Treatment will consist of the application of topical 10% or 15% KOH in an aqueous solution for the two treatment groups, compared to a placebo-treated control group. Topical Application.
DRUG	Placebo

Timeline

• Start date: 2010-03-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2011-05-05
• Last updated: 2015-10-01

Locations

1 site across 1 country: Spain