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

Completed

• Conditions: Diaper Rash

• Registration Number: NCT05599763
• Lead Sponsor: Cooperation Pharmaceutique Francaise

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-26
• Study First Submitted QC: 2022-10-26
• Study First Posted: 2022-10-31
• Study Start: 2022-11-04
• Primary Completion: 2023-04-19
• Study Completion: 2023-04-19
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients with an SSDDS score < 3/6 or an improvement of at least 2 points	at day 7 +-2 days	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).

Secondary Outcome Measures

Name	Time	Method
Percentage of patients completely cured	at day 7 +/-2 days
Change of the SSDDS score between day 0 and day 7	at day 7 +/-2 days	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).
Healing time according to parent	up to 9 days
Assessment of tolerance	at day 7 +/-2 days	Tolerance is measured by adverse events reported
Assessment of compliance	at day 7 +/-2 days	According to the judgment of the investigator
Change in associated signs between day 0 and day 7	at day 7 +/-2 days

Trial Locations

Locations (1)

Multiple locations; 🇫🇷 Multiple Locations, France