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

Cooperation Pharmaceutique Francaise

Status: Completed

Conditions: Diaper Rash

Study type: Observational

Funder types: Industry

Identifiers

NCT05599763

2022-A01221-42

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Ages: Under 24 months old

Volunteers: No Healthy Volunteers

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).