Molluscum Contagiosum | Efficacy and Tolerance of Potassium Hydroxide (10% and 15%) in Molluscum Contagiosum
Molluscum Contagiosum research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Hydroxide PotassiumTreatment 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.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
KOH 10%Treatment consists of the application of topical 10% KOH in an aqueous solution.
KOH 15%Treatment consists of the application of topical 15% KOH in an aqueous solution
PLACEBO100 milliliters of saline solution
Start Date: March 2010
Completed Date: March 2012
Phase: Phase 2/Phase 3
Primary Outcome: Efficacy (diseappearance of lesions)
Study sponsors, principal investigator, and references
Lead Sponsor: Jordi Gol i Gurina Foundation