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

NCT01348386 | Completed Phase 2

• 1 other identifier: EC08/00011
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Molluscum Contagiosum

Keywords

Potassium hydroxide.; Molluscum Contagiosum

Outcome Measures

Primary Outcomes (1)

• Efficacy (diseappearance of lesions)

  60 days

Study Arms (3)

KOH 10%

EXPERIMENTAL

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

Drug: Hydroxide Potassium

KOH 15%

EXPERIMENTAL

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

Drug: Hydroxide Potassium

PLACEBO

PLACEBO COMPARATOR

100 milliliters of saline solution

Drug: Placebo

Interventions

Hydroxide Potassium DRUG

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 10%; KOH 15%

Placebo DRUG

PLACEBO

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead

Study Sites (1)

CAP Rambla Ferran

Lleida, Catalonia, 25001, Spain

Location

Related Publications (1)

• 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.

  PMID: 22011376 DERIVED

MeSH Terms

Conditions

Molluscum Contagiosum

Interventions

potassium hydroxide

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2011
• First Posted: May 5, 2011
• Study Start: March 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: October 1, 2015

Record last verified: 2011-05

Locations

ES (1)