Multicenter, National, Observational, Prospective, Real-l... | NCT05599763

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

NCT05599763

Sponsor

Cooperation Pharmaceutique Francaise

Status

Completed

Last Update Posted

Jun 24, 2026Actual

Enrollment

67Actual

Phase

Not provided

Conditions

Diaper Rash

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 4, 2022Actual

Primary Completion Date

Apr 19, 2023Actual

Completion Date

Apr 19, 2023Actual

First Submitted Date

Oct 26, 2022

First Submission Date that Met QC Criteria

Oct 26, 2022

First Posted Date

Oct 31, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2026

Last Update Posted Date

Jun 24, 2026Actual

Name	Class
Clin-Experts	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

67Actual

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

24 Months

Standard Ages

Child

Study Population

Patients seen in consultation by French general practitioners and pediatricians

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Frédéric HUET	CHU DIJON	Principal Investigator

References Module

Citations

Not provided

ID	Term
D017453	Dermatitis, Irritant
D003877	Dermatitis, Contact
D003872	Dermatitis
D012871	Skin Diseases