Real-life Study Evaluating the Performance of 2% Aqueous Eosin in Children With Diaper Rash
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Percentage of patients with an SSDDS score < 3/6 or an improvement of at least 2 points
研究概览
简要总结
This study is being conducted to provide updated clinical data on safety and performance (demonstrated previously for CE marking under the Medical Devices Directive) Cooper Aqueous Eosin 2%. This is an observational study conducted under real-life conditions and as part of post-marketing surveillance activity for a device that has been on the market for a long time and a well-established technology, in accordance with the Medical Devices Regulations 2017 /745 (MDR) and MDCG 2020-6 guidelines.
The study will be a multicenter, national, observational, prospective study, with a 7-day follow-up (+/- 2 day). 60 patients are scheduled.
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
- — 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children under 24 months
- •With diaper rash for which a prescription for 2% aqueous eosin in a 50 ml vial is made
- •SSDDS score >= 3/6
- •Not requiring hospitalization
- •Written consent of one of the parents
- •Affiliated with social security
- •Acceptance of one of the parents to participate in a visit on day 7 in the office or, in case of impossibility, with video/internet consultation or with consultation by phone and sending a photo in this case by the parent(s).
排除标准
- •Antibiotic therapy in progress or prescribed on day 0, or other local therapeutic topicals prescribed on day 0
- •Children with wounds or likely to be allergic to 2% aqueous eosin or to one of the components of 2% aqueous eosin.
- •Ongoing diarrhoea (change in the consistency of stools (loose or watery) and / or an increase in the number (≥ 3 stools / day).
结局指标
主要结局
Percentage of patients with an SSDDS score < 3/6 or an improvement of at least 2 points
时间窗: at day 7 +-2 days
The SSDDS (Scoring System for Diaper Dermatitis Scale) score is a severity score : the sum of the scores for four areas: severity of erythema and irritation (score from 0 to 3), extension (0 to 1), presence of papules or pustules (0 to 1) and open skin (0 to 1). The possible scores range from 0 (fair skin) to 6 (extensive diaper rash including intense erythema, papules or pustules and open skin with lesion of the dermis).
次要结局
- Percentage of patients completely cured(at day 7 +/-2 days)
- Change of the SSDDS score between day 0 and day 7(at day 7 +/-2 days)
- Assessment of compliance(at day 7 +/-2 days)
- Healing time according to parent(up to 9 days)
- Assessment of tolerance(at day 7 +/-2 days)
- Change in associated signs between day 0 and day 7(at day 7 +/-2 days)