An observational study in Diaper Rash, sponsored by Cooperation Pharmaceutique Francaise. Completed at 1 site in France. Open to participants aged Up to 24 Months. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by Cooperation Pharmaceutique Francaise · Observational
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.
38 studies on the registry are indexed under Diaper Rash; 4 are open to participants now.
Browse Diaper Rash studies →This is the only study on the registry with Cooperation Pharmaceutique Francaise as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Patients seen in consultation by French general practitioners and pediatricians
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Exclusion Criteria:
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).
Time frame: at day 7 +-2 days
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
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).
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
Tolerance is measured by adverse events reported
Time frame: at day 7 +/-2 days
Assessment of compliance
According to the judgment of the investigator
Time frame: at day 7 +/-2 days
Plan to share: No
Ran from Nov 2022 to primary completion in Apr 2023, 5 months.
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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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