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

Study Overview
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Brief Summary
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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.

Official Title
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Real-life Study Evaluating the Performance of 2% Aqueous Eosin in Children With Diaper Rash

Conditions
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Diaper Rash

Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with an SSDDS score < 3/6 or an improvement of at least 2 points | The SSDDS (Scoring System for Diaper Dermatitis Scale) score is a severity score : the sum of the scores for four areas: severity of erythema and irritation (score from 0 to 3), extension (0 to 1), presence of papules or pustules (0 to 1) and open skin (0 to 1). The possible scores range from 0 (fair skin) to 6 (extensive diaper rash including intense erythema, papules or pustules and open skin with lesion of the dermis). | at day 7 +-2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients completely cured |  | at day 7 +/-2 days | 
| Healing time according to parent |  | up to 9 days | 
| Change of the SSDDS score between day 0 and day 7 | The SSDDS (Scoring System for Diaper Dermatitis Scale) score is a severity score : the sum of the scores for four areas: severity of erythema and irritation (score from 0 to 3), extension (0 to 1), presence of papules or pustules (0 to 1) and open skin (0 to 1). The possible scores range from 0 (fair skin) to 6 (extensive diaper rash including intense erythema, papules or pustules and open skin with lesion of the dermis). | at day 7 +/-2 days | 
| Change in associated signs between day 0 and day 7 |  | at day 7 +/-2 days | 
| Assessment of tolerance | Tolerance is measured by adverse events reported | at day 7 +/-2 days | 
| Assessment of compliance | According to the judgment of the investigator | at day 7 +/-2 days |