Efficacy and Tolerance of the Topical Application of Potassium Hydroxide (10% and 15%) in the Treatment of Molluscum Contagiosum
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Efficacy (diseappearance of lesions)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
KOH 10%
Treatment consists of the application of topical 10% KOH in an aqueous solution.
干预措施: Hydroxide Potassium (Drug)
KOH 15%
Treatment consists of the application of topical 15% KOH in an aqueous solution
干预措施: Hydroxide Potassium (Drug)
PLACEBO
100 milliliters of saline solution
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacy (diseappearance of lesions)
时间窗: 60 days
次要结局
未报告次要终点