Multicenter National Observational and Prospective Study of a Cohort of Children With Molluscum Contagiosum (MC) Treated With a 5% Solution of Potassium Hydroxide (Molutrex®) Applied Locally to the Skin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Percentage of children healed healing defined by a decrease of more than 90% in the number of lesions present at D0.
研究概览
简要总结
Molutrex® a 5% potassium hydroxide solution for topical application to the skin. Molutrex® is intended for the superficial treatment of certain types of warts, molluscum contagiosum and is composed of potassium hydroxide (5%) purified water. With regard to the 2017/745 RDM, he is a class IIa medical device. In accordance with Regulation (EU) 2017/745 of the European Parliament and of the Council of April 5, 2017 relating to medical devices, as part of the Molutrex® Post-Marketing Monitoring Plan, the objective of this study is to have data on the performance , safety and suitability for real-life use of Molutrex® in a prospective cohort of patients with molluscum contagiosum.
Since molluscum contagiosum is most prevalent in children, and potassium hydroxide is used very little in adults (because most often they are immunocompromised patients requiring other antiviral treatments), the study will be conducted in children aged 2 to 10 years. This population represents the majority of patients treated with Molutrex®, although the product can be used in adults. The study includes 2 visits, the objective of the study being to evaluate the percentage of children healed at 45 days, healing defined by a reduction of more than 90% in the number of lesions present at inclusion in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child aged 2 to 10 years old :
- •Ambulatory
- •Seen in dermatology consultation for molluscum contagiosum
- •For which a treatment with a 5% solution of potassium hydroxide (Molutrex®) in local cutaneous application has been decided by the dermatologist as monotherapy
- •Not treated for their molluscum contagiosum in the previous month
- •For which one of the parents gives their written consent to participate
排除标准
- •Doubt about the diagnosis of molluscum contagiosum Molluscum contagiosum surge already treated Immunocompromised child Atopic eczema in outbreak Lesions around the eye
结局指标
主要结局
Percentage of children healed healing defined by a decrease of more than 90% in the number of lesions present at D0.
时间窗: at day 45 +- 2 days
次要结局
- Percentage change in the number of lesions compared to D0(at day 45 +- 2 days)
- Percentage of children in whom new lesions appeared since inclusion according to the parents(at day 45 +- 2 days)
- Percentage of patients according to the reduction in the number of lesions compared to D0(at day 45 +- 2 days)
- Assessment of the ability to use the treatment(at day 45 +- 2 days)
- Assessment of tolerance(at day 45 +- 2 days)
- Time of disappearance of the initial lesions (judgment of the parents)(up to 45 days)
- Occurrence of contamination of a subject of the family since inclusion(at day 45 +- 2 days)
- Compliance with the terms of use of the prescribed treatment(at day 45 +- 2 days)
- Disappearance of pruritus since inclusion(at day 45 +- 2 days)