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

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

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.

Study Overview

• Status: Completed
• Conditions: Diaper Rash

• Study Type: Observational
• Enrollment (Actual): 67

Contacts and Locations

• Study Contact: Name: Renaud URBINELLI; Phone Number: +33 6 58 68 72 86; Email: contact@clin-experts.fr

Study Locations

• France
  • Multiple Locations, France
    • Multiple locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients seen in consultation by French general practitioners and pediatricians

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cooperation Pharmaceutique Francaise
• Collaborators: Clin-Experts
• Investigators: Principal Investigator: Frédéric HUET, CHU Dijon

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2022
• Primary Completion (Actual): April 19, 2023
• Study Completion (Actual): April 19, 2023

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: October 26, 2022
• First Posted (Actual): October 31, 2022

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Skin Diseases, Eczematous; Dermatitis, Irritant; Dermatitis, Contact; Diaper Rash
• Other Study ID Numbers: 2022-A01221-42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No