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Multicenter, National, Observational, Prospective, Real-life Study Evaluating the Performance of 2% Aqueous Eosin in Children With Diaper Rash
Sponsor: Cooperation Pharmaceutique Francaise
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.
Official title: Real-life Study Evaluating the Performance of 2% Aqueous Eosin in Children With Diaper Rash
Key Details
Gender
All
Age Range
Any - 24 Months
Study Type
OBSERVATIONAL
Enrollment
67
Start Date
2022-11-04
Completion Date
2023-04-19
Last Updated
2026-06-24
Healthy Volunteers
No
Conditions
Locations (1)
Multiple locations
Multiple Locations, France