CompletedNot Applicable

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

France67 participantsStarted 2022-11-04

Plain-language 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.

Who can participate

Age range24 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 by phone and sending a photo in this case by the parent(s). Exclusion Criteria: * Antibiotic therapy in progress or prescribed on day 0, or other local therapeutic topicals prescribed on day 0 * Children with wounds or likely to be allergic to 2% aqueous eosin or to one of the components of 2% aqueous eosin. * Ongoing diarrhoea (change in the consistency of stools (loose or watery) and / or an increase in the number (≥ 3 stools / day).

What they're measuring

Percentage of patients with an SSDDS score < 3/6 or an improvement of at least 2 points

Timeframe: at day 7 +-2 days

Trial details

NCT IDNCT05599763

SponsorCooperation Pharmaceutique Francaise

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-04-19