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

NCT02193230 | Completed

• 1 other identifier: RC14_0073
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis, Feasibility, Adherence to treatment

Outcome Measures

Primary Outcomes (1)

• Assess the feasibility of giving the choice to the patient/parent of different galenic in atopic dermatitis.

  Assess the feasibility of giving the choice to the patient/parent of different galenic in atopic dermatitis. The primary outcome is evaluated through a questionnaire given to the patient/parent at day 0 day 30 day 90.

  90 days

Secondary Outcomes (4)

• Evaluate the impact of this procedure in patient adherence to treatment (trough weighing treatments at day 30 and day 90)

  90 days

• Evaluate the impact of this procedure on the evolution of the disease

  90 days

• Assess the feasibility point of view of the prescribing physician

  90 days

• Measuring the characteristics of a specified product and those of a product chosen by the patient

  90 days

Eligibility Criteria

• Age: 3 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Multicenter prospective nonrandomized uncontrolled open-label study

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU de Nantes

Nantes, 44093, France

Location

Related Links

• PO SCORAD

MeSH Terms

Conditions

Dermatitis, Atopic; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Health Behavior; Behavior

Study Officials

• Jean-François Stalder, PU-PH

  Nantes University Hospital

  STUDY DIRECTOR

• Jean-Marc Chavigny, PH

  Centre Pasteur Dermatologie

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 15, 2014
• First Posted: July 17, 2014
• Study Start: October 14, 2014
• Primary Completion: September 30, 2015
• Study Completion: October 31, 2015
• Last Updated: September 16, 2021

Record last verified: 2021-09

Locations

FR (1)