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

Phase 2

Completed

• Conditions: Molluscum Contagiosum
• Interventions: Drug: Hydroxide Potassium; Drug: Placebo

• Registration Number: NCT01348386
• Lead Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

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 Description

Not available

Study Timeline

• Study Start: 2010-03
• Status Verified: 2011-05
• Study First Submitted: 2011-05-04
• Study First Submitted QC: 2011-05-04
• Study First Posted: 2011-05-05
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Last Update Submitted: 2015-09-30
• Last Update Posted: 2015-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

• Who are diagnosed with a molluscum contagiosum (MC) infection (clinical diagnosis).
• Who are between the ages of two and six.
• Whose parents or guardians have provided written informed consent for participation.

Exclusion Criteria

• Immunocompromised patient (congenital or acquired).
• Patient has received other topical treatment within the last month.
• Patient has lesions on face, neck or genital area.
• Patient who, in the view of the attending physician, will not comply with treatment and/or scheduled visits.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KOH 10%	Hydroxide Potassium	Treatment consists of the application of topical 10% KOH in an aqueous solution.
KOH 15%	Hydroxide Potassium	Treatment consists of the application of topical 15% KOH in an aqueous solution
PLACEBO	Placebo	100 milliliters of saline solution

Primary Outcome Measures

Name	Time	Method
Efficacy (diseappearance of lesions)	60 days

Trial Locations

Locations (1)

CAP Rambla Ferran; 🇪🇸 Lleida, Catalunya, Spain