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

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ClinicalTrials.gov Identifier: NCT01348386
Recruitment Status : Completed
First Posted : May 5, 2011
Last Update Posted : October 1, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment Phase
Molluscum Contagiosum Drug: Hydroxide Potassium Drug: Placebo Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : March 2010
Primary Completion Date : March 2012
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Efficacy (diseappearance of lesions) [ Time Frame: 60 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: May 5, 2011    Key Record Dates
Last Update Posted: October 1, 2015
Last Verified: May 2011

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