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

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Key information

Conditions

Molluscum Contagiosum DNA Virus Infections Infections Poxviridae Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Virus Diseases

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

CAP Rambla Ferran

Lleida, Catalonia, 25001, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hydroxide Potassium

Drug

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

Drug

Primary outcomes

Efficacy (diseappearance of lesions)

Time frame: 60 days

Sponsors and collaborators

Lead sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Other

Registry information

Official study title

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

Acronym: EKOH-MOL 2008

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: May 5, 2011
Registry last updated: Oct 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed