Diaper Rash
Conditions
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.
Interventions
None listed
Sponsors
Cooperation Pharmaceutique Francaise
Clin-Experts
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 24 Months
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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). |
| Change in associated signs between day 0 and day 7 | at day 7 +/-2 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 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORFrédéric HUET
CHU DIJON
Outcome results
None listed