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

Study Overview
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Brief Summary
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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.

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

Conditions
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Molluscum Contagiosum

Intervention / Treatment
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* Drug: Hydroxide Potassium
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KOH 10%<br>Treatment consists of the application of topical 10% KOH in an aqueous solution. | Drug: Hydroxide Potassium<br>* 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.<br>|
| Experimental: KOH 15%<br>Treatment consists of the application of topical 15% KOH in an aqueous solution | Drug: Hydroxide Potassium<br>* 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.<br>|
| Placebo Comparator: PLACEBO<br>100 milliliters of saline solution | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy (diseappearance of lesions) |  | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Potassium hydroxide., Molluscum Contagiosum