Taking Into Account the Patient/Parent Preference in the Galenic Choice in Atopic Dermatitis. Feasibility and Impact on Treatment Adherence

NCT ID: NCT02193230

Last Updated: 2021-09-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-10-14
• Study Completion Date: 2015-10-31

Brief Summary

Atopic dermatitis is a chronic inflammatory skin disease often occurring in childhood.

The treatment consists in making daily local treatment with topical steroid on inflammatory lesions and emollient on the whole body. However, approximately 70% of patients do not adhere to therapy.

Studies have shown that this treatment failure is caused by the complexity of the treatment, the time required for its implementation, the cost of treatment, the dosage of the products, fear of side effects or misunderstanding about the chronicity of these diseases inflammatory conditions of the skin.

This study aims to evaluate the consideration of patient preference in the choice of excipient used for the topical treatment of eczema.

Detailed Description

Day 0 :

• Inclusion, collecting non-opposition
• Presentation of the samples: 4 products presented in the same packaging (pump bottle 200 ml) and ranked in order of their fat content:
• Cold Cream: 88%
• Modified Cerat Galen (national formulary): 66%
• Cold Cream Fluid: 32%
• Ointment: 21% The 4 products are all equally effective and suited in the treatment of atopic dermatitis.

The patient choose the cream it will apply from 4 presented. A total of two bottles will be given to the patient. A bottle containing only the emollient applied to dry areas and another bottle in which 30% will be added Diprosone (topical steroid) to be applied on areas of eczema).

• Remitting the questionnaires
• Severity scoring of atopic dermatitis (SCORAD)

Day 30:

• Remitting the questionnaires
• Treatments delivery for 2 months
• SCORAD / PO SCORAD
• Treatment weighing

Day 90:

• SCORAD / PO-SCORAD
• Treatments weighing
• Remitting the final questionnaire

Conditions

Atopic Dermatitis

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

Patients experiencing treatment failure despite appropriate treatment. Patients minors aged between 3 and 15 years For children age 7 and non-autonomous children in the application of treatment, the parent at the initial consultation should be the one who treats the child.

Information from both parents or parental authority and collection of Non-Opposition The patient must have a computer to do its PO-SCORAD between consultations. Patient who used a topical treatment for atopic dermatitis in the week preceding the study.

Exclusion Criteria

Patient refusal to participate in the clinical study. Adults and children over 15 years.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-François Stalder, PU-PH

Role: STUDY_DIRECTOR

Nantes University Hospital

Jean-Marc Chavigny, PH

Role: PRINCIPAL_INVESTIGATOR

Centre Pasteur Dermatologie

Locations

CHU de Nantes

Nantes, , France

Countries

France

Related Links

http://www.decas.univ-nantes.fr/GET/GET/POSCORAD_files/Po-Scorad_FR.pdf

PO SCORAD

Other Identifiers

RC14_0073

Identifier Type: -

Identifier Source: org_study_id