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

NCT05599763 | Completed

• 1 other identifier: 2022-A01221-42
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Diaper Rash

Outcome Measures

Primary Outcomes (1)

• 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 (6)

• 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

• Change in associated signs between day 0 and day 7

  at day 7 +/-2 days

• Assessment of tolerance

  at day 7 +/-2 days

Eligibility Criteria

• Age: Up to 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients seen in consultation by French general practitioners and pediatricians

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cooperation Pharmaceutique Francaise: lead
• Clin-Experts: collaborator

Study Sites (1)

Multiple locations

Multiple Locations, France

Location

MeSH Terms

Conditions

Diaper Rash

Condition Hierarchy (Ancestors)

Dermatitis, Irritant; Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Officials

• Frédéric HUET

  CHU DIJON

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: October 31, 2022
• Study Start: November 4, 2022
• Primary Completion: April 19, 2023
• Study Completion: April 19, 2023
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)