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

NCT05599763 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 67

Last updated 2024-02-08

No results posted yet for this study

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.

Conditions

  • Diaper Rash

Sponsors & Collaborators

  • Clin-Experts

    collaborator INDUSTRY

  • Cooperation Pharmaceutique Francaise

    lead INDUSTRY

Principal Investigators

  • Frédéric HUET · CHU DIJON

Eligibility

Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-04
Primary Completion
2023-04-19
Completion
2023-04-19

Countries

  • France

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05599763 on ClinicalTrials.gov