Multicenter, National, Observational, Prospective, Real-life Study Evaluating the Performance of … (NCT05599763) | Clinical Trial Compass
CompletedNot Applicable
Multicenter, National, Observational, Prospective, Real-life Study Evaluating the Performance of 2% Aqueous Eosin in Children With Diaper Rash
France67 participantsStarted 2022-11-04
Plain-language summary
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.
Who can participate
Age range
24 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of patients with an SSDDS score < 3/6 or an improvement of at least 2 points