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

Molluscum Contagiosum Clinical Trial

— EKOH-MOL 2008  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01348386
• Other study ID #: EC08/00011
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 4, 2011
• Last updated: September 30, 2015
• Start date: March 2010
• Est. completion date: March 2012

Study information

• Verified date: May 2011
• Source: Jordi Gol i Gurina Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 6 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Molluscum Contagiosum

Intervention

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.
• Placebo

Locations

Country	Name	City	State
Spain	CAP Rambla Ferran	Lleida	Catalunya

Sponsors (1)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy (diseappearance of lesions)		60 days	No