Efficacy and Tolerance of Potassium Hydroxide (10% and 15%) in Molluscum Contagiosum (EKOH-MOL 2008)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier:
NCT01348386
First received: May 4, 2011
Last updated: September 30, 2015
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Molluscum Contagiosum
Drug: Hydroxide Potassium
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Tolerance of the Topical Application of Potassium Hydroxide (10% and 15%) in the Treatment of Molluscum Contagiosum

Resource links provided by NLM:


Further study details as provided by Jordi Gol i Gurina Foundation:

Primary Outcome Measures:
  • Efficacy (diseappearance of lesions) [ Time Frame: 60 days ] [ Designated as safety issue: No ]

Enrollment: 53
Study Start Date: March 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KOH 10%
Treatment consists of the application of topical 10% KOH in an aqueous solution.
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.
Experimental: KOH 15%
Treatment consists of the application of topical 15% KOH in an aqueous solution
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 Comparator: PLACEBO
100 milliliters of saline solution
Drug: Placebo

  Eligibility

Ages Eligible for Study:   2 Years to 6 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01348386

Locations
Spain
CAP Rambla Ferran
Lleida, Catalunya, Spain, 25001
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT01348386     History of Changes
Other Study ID Numbers: EC08/00011 
Study First Received: May 4, 2011
Last Updated: September 30, 2015
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Jordi Gol i Gurina Foundation:
Potassium hydroxide.
Molluscum Contagiosum

Additional relevant MeSH terms:
Molluscum Contagiosum
Poxviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on July 25, 2016