A Phase 2/3 interventional study of Hydroxide Potassium and Placebo in Molluscum Contagiosum, sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina. Completed at 1 site in Spain. Open to participants aged 2 Years to 6 Years. Per ClinicalTrials.gov, last updated 2015-10-01.
Sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina · Phase 2/3, Interventional, and Treatment
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.
22 studies on the registry are indexed under Molluscum Contagiosum; none are open to participants now.
This study's enrollment of 53 is below the median of 94 across 19 interventional studies indexed under Molluscum Contagiosum.
Browse Molluscum Contagiosum studies →Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina is the lead sponsor of 158 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment consists of the application of topical 10% KOH in an aqueous solution.
Drug: Hydroxide Potassium
Treatment consists of the application of topical 15% KOH in an aqueous solution
Drug: Hydroxide Potassium
100 milliliters of saline solution
Drug: Placebo
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.
Efficacy (diseappearance of lesions)
Time frame: 60 days
This study is completed, as verified in May 2011. You cannot join it, but the record below documents what was studied.
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Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina