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

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Status and phase: Completed; Phase 3; Phase 2

Conditions: Molluscum Contagiosum

Treatments: Drug: Placebo; Drug: Hydroxide Potassium

Study type: Interventional

Funder types: Other

Identifiers

NCT01348386

EC08/00011

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 2 to 6 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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53 participants in 3 patient groups, including a placebo group

KOH 10%

Experimental group

Description:

Treatment consists of the application of topical 10% KOH in an aqueous solution.

Treatment:

Drug: Hydroxide Potassium

KOH 15%

Experimental group

Description:

Treatment consists of the application of topical 15% KOH in an aqueous solution

Treatment:

Drug: Hydroxide Potassium

PLACEBO

Placebo Comparator group

Description:

100 milliliters of saline solution

Treatment:

Drug: Placebo