Trials / Completed
CompletedNCT05599763
Multicenter, National, Observational, Prospective, Real-life Study Evaluating the Performance of 2% Aqueous Eosin in Children With Diaper Rash
Real-life Study Evaluating the Performance of 2% Aqueous Eosin in Children With Diaper Rash
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 67 (actual)
- Sponsor
- Cooperation Pharmaceutique Francaise · Industry
- Sex
- All
- Age
- 24 Months
- Healthy volunteers
- Not accepted
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
Timeline
- Start date
- 2022-11-04
- Primary completion
- 2023-04-19
- Completion
- 2023-04-19
- First posted
- 2022-10-31
- Last updated
- 2024-02-08
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT05599763. Inclusion in this directory is not an endorsement.