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Completed

NCT Number: NCT05599763

Multicenter, National, Observational, Prospective, 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.

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Key information

Conditions

Diaper Rash Dermatitis Dermatitis, Contact Dermatitis, Irritant Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases

Age range

Up to 24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple locations

Multiple Locations, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. 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).

Secondary outcomes

  1. Percentage of patients completely cured

    Time frame: at day 7 +/-2 days

  2. Healing time according to parent

    Time frame: up to 9 days

  3. Change of the SSDDS score between day 0 and day 7

    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).

  4. Change in associated signs between day 0 and day 7

    Time frame: at day 7 +/-2 days

  5. Assessment of tolerance

    Time frame: at day 7 +/-2 days

    Tolerance is measured by adverse events reported

  6. Assessment of compliance

    Time frame: at day 7 +/-2 days

    According to the judgment of the investigator

Sponsors and collaborators

Lead sponsor

Cooperation Pharmaceutique Francaise

Industry

Collaborators

  • Clin-Experts

Registry information

Official study title

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

Acronym: EA2

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 31, 2022
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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