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Multicenter, National, Observational, Prospective, Real-life Study Evaluating the Performance of 2% Aqueous Eosin in Children With Diaper Rash — EA2  

Diaper Rash Clinical Trial

Official title:
Real-life Study Evaluating the Performance of 2% Aqueous Eosin in Children With Diaper Rash

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05599763
Study type Observational
Source Cooperation Pharmaceutique Francaise
Contact
Status Completed
Phase
Start date November 4, 2022
Completion date April 19, 2023
View Details
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