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

Diaper Rash Clinical Trial

— EA2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05599763
• Other study ID #: 2022-A01221-42
• Status: Completed
• Start date: November 4, 2022
• Est. completion date: April 19, 2023

Study information

• Verified date: February 2024
• Source: Cooperation Pharmaceutique Francaise
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: April 19, 2023
• Est. primary completion date: April 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 24 Months

Eligibility

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).

Related Conditions & MeSH terms

• Diaper Rash

Locations

Country	Name	City	State
France	Multiple locations	Multiple Locations

Sponsors (2)

Lead Sponsor	Collaborator
Cooperation Pharmaceutique Francaise	Clin-Experts

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of patients completely cured		at day 7 +/-2 days
Secondary	Healing time according to parent		up to 9 days
Secondary	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
Secondary	Change in associated signs between day 0 and day 7		at day 7 +/-2 days
Secondary	Assessment of tolerance	Tolerance is measured by adverse events reported	at day 7 +/-2 days
Secondary	Assessment of compliance	According to the judgment of the investigator	at day 7 +/-2 days