Skip to main content
OpenTrials
Completed

NCT Number: NCT02193230

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

3 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nantes

Nantes, 44093, France

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 90 days

    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.

Secondary outcomes

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

    Time frame: 90 days

  2. Evaluate the impact of this procedure on the evolution of the disease

    Time frame: 90 days

    Evaluate the impact of this procedure on the evolution of the disease (trough SCORAD and PO-SCORAD at day 0, day 30, day 90)

  3. Assess the feasibility point of view of the prescribing physician

    Time frame: 90 days

    • Assess the feasibility point of view of the prescribing physician (through questionnaires at day 0 day 30 day 90)

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

    Time frame: 90 days

    • Measuring the characteristics of a specified product and those of a product chosen by the patient (through questionnaires at day 0, day 30, day 90)

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: DACE

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 17, 2014
Registry last updated
Sep 16, 2021

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.