Diaper RashEA2NCT05599763
Multicenter, National, Observational, Prospective, Real-life Study Evaluating the Performance of 2% Aqueous Eosin in Children With Diaper Rash
An observational study of Diaper Rash, run by Cooperation Pharmaceutique Francaise at 1 site in France.
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%. Read more about this study
- Who is it for?
- Ages Up to 24 months
- Conditions the study is for
- Diaper Rash
- How many people
- 67 participants
- Where
- 1 siteFrance
- Study dates
- 4 Nov 2022to 19 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 months
- All sexes
- No healthy volunteers
- Child
Study population: Patients seen in consultation by French general practitioners and pediatricians
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Diaper Rash
- Medical subject headings
- Diaper Rash
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: at day 7 +-2 days
Secondary outcomes (6)
Percentage of patients completely cured
Measured: at day 7 +/-2 days
Healing time according to parent
Measured: 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).
Measured: at day 7 +/-2 days
Change in associated signs between day 0 and day 7
Measured: at day 7 +/-2 days
Assessment of tolerance
Tolerance is measured by adverse events reported
Measured: at day 7 +/-2 days
Assessment of compliance
According to the judgment of the investigator
Measured: at day 7 +/-2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start4 Nov 2022
- Primary completion19 Apr 2023
- Study completion19 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaper RashStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cooperation Pharmaceutique Francaise
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clin-Experts
- Responsible party
- Sponsor
- Investigators
- Frédéric HUET, Principal investigator, CHU DIJON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599763
- Sponsor's protocol ID
- 2022-A01221-42
- Acronym
- EA2
- Status last verified
- Jun 2026
- First submitted
- 26 Oct 2022
- Last updated
- 24 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-life Study Evaluating the Performance of 2% Aqueous Eosin in Children With Diaper Rash
- ClinicalTrials.gov ID
- NCT05599763
- Acronym / sponsor ID
- EA2 / 2022-A01221-42
- Conditions
- Diaper Rash
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Cooperation Pharmaceutique FrancaiseIndustry (pharma, biotech, devices)
- Collaborators
- Clin-Experts
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- 19 Apr 2023 (actual)
- Study completion
- 19 Apr 2023 (actual)
- First posted
- 31 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients seen in consultation by French general practitioners and pediatricians
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of patients with an SSDDS score < 3/6 or an improvement of at least 2 points
Time frame: 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).
6 secondary outcomes
Percentage of patients completely cured
Time frame: at day 7 +/-2 days
Healing time according to parent
Time frame: up to 9 days
Change of the SSDDS score between day 0 and day 7
Time frame: at day 7 +/-2 days
Change in associated signs between day 0 and day 7
Time frame: at day 7 +/-2 days
Assessment of tolerance
Time frame: at day 7 +/-2 days
Assessment of compliance
Time frame: at day 7 +/-2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Multicenter, national, observational, prospective, real-life study evaluating the performance of 2% aqueous eosin in children with diaperLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédéric HUET principal investigator
CHU DIJON
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diaper Rash, run by Cooperation Pharmaceutique Francaise at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with an SSDDS score < 3/6 or an improvement of at least 2 points (time frame: at day 7 +-2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.