Efficacy and Tolerance of Potassium Hydroxide (10% and 15%) in Molluscum Contagiosum
NCT ID: NCT01348386
Last Updated: 2015-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
53 participants
INTERVENTIONAL
2010-03-31
2012-03-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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KOH 10%
Treatment consists of the application of topical 10% KOH in an aqueous solution.
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.
KOH 15%
Treatment consists of the application of topical 15% KOH in an aqueous solution
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
100 milliliters of saline solution
Placebo
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Who are between the ages of two and six.
* Whose parents or guardians have provided written informed consent for participation.
Exclusion Criteria
* 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.
2 Years
6 Years
ALL
No
Sponsors
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Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
OTHER
Responsible Party
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Locations
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CAP Rambla Ferran
Lleida, Catalonia, Spain
Countries
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References
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Marsal JR, Cruz I, Teixido C, Diez O, Martinez M, Galindo G, Real J, Schoenenberger JA, Pera H. Efficacy and tolerance of the topical application of potassium hydroxide (10% and 15%) in the treatment of molluscum contagiosum: randomized clinical trial: research protocol. BMC Infect Dis. 2011 Oct 19;11:278. doi: 10.1186/1471-2334-11-278.
Other Identifiers
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EC08/00011
Identifier Type: -
Identifier Source: org_study_id
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