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

Last updated: February 7, 2024
Sponsor: Cooperation Pharmaceutique Francaise
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05599763
2022-A01221-42
  • Ages < 24
  • All Genders

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.

Eligibility Criteria

Inclusion

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 byphone and sending a photo in this case by the parent(s).

Exclusion

Exclusion Criteria:

  • Antibiotic therapy in progress or prescribed on day 0, or other local therapeutictopicals prescribed on day 0
  • Children with wounds or likely to be allergic to 2% aqueous eosin or to one of thecomponents of 2% aqueous eosin.
  • Ongoing diarrhoea (change in the consistency of stools (loose or watery) and / or anincrease in the number (≥ 3 stools / day).

Study Design

Total Participants: 67
Study Start date:
November 04, 2022
Estimated Completion Date:
April 19, 2023

Connect with a study center

  • Multiple locations

    Multiple Locations,
    France

    Site Not Available

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