<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02193230</url>
  </required_header>
  <id_info>
    <org_study_id>RC14_0073</org_study_id>
    <nct_id>NCT02193230</nct_id>
  </id_info>
  <brief_title>Taking Into Account the Patient/Parent Preference in the Galenic Choice in Atopic Dermatitis. Feasibility and Impact on Treatment Adherence</brief_title>
  <acronym>DACE</acronym>
  <official_title>Taking Into Account the Patient/Parent Preference in the Galenic Choice in Atopic Dermatitis. Feasibility and Impact on Treatment Adherence.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nantes University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Atopic dermatitis is a chronic inflammatory skin disease often occurring in childhood.&#xD;
&#xD;
      The treatment consists in making daily local treatment with topical steroid on inflammatory&#xD;
      lesions and emollient on the whole body. However, approximately 70% of patients do not adhere&#xD;
      to therapy.&#xD;
&#xD;
      Studies have shown that this treatment failure is caused by the complexity of the treatment,&#xD;
      the time required for its implementation, the cost of treatment, the dosage of the products,&#xD;
      fear of side effects or misunderstanding about the chronicity of these diseases inflammatory&#xD;
      conditions of the skin.&#xD;
&#xD;
      This study aims to evaluate the consideration of patient preference in the choice of&#xD;
      excipient used for the topical treatment of eczema.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Day 0 :&#xD;
&#xD;
        -  Inclusion, collecting non-opposition&#xD;
&#xD;
        -  Presentation of the samples: 4 products presented in the same packaging (pump bottle 200&#xD;
           ml) and ranked in order of their fat content:&#xD;
&#xD;
        -  Cold Cream: 88%&#xD;
&#xD;
        -  Modified Cerat Galen (national formulary): 66%&#xD;
&#xD;
        -  Cold Cream Fluid: 32%&#xD;
&#xD;
        -  Ointment: 21% The 4 products are all equally effective and suited in the treatment of&#xD;
           atopic dermatitis.&#xD;
&#xD;
      The patient choose the cream it will apply from 4 presented. A total of two bottles will be&#xD;
      given to the patient. A bottle containing only the emollient applied to dry areas and another&#xD;
      bottle in which 30% will be added Diprosone (topical steroid) to be applied on areas of&#xD;
      eczema).&#xD;
&#xD;
        -  Remitting the questionnaires&#xD;
&#xD;
        -  Severity scoring of atopic dermatitis (SCORAD)&#xD;
&#xD;
      Day 30:&#xD;
&#xD;
        -  Remitting the questionnaires&#xD;
&#xD;
        -  Treatments delivery for 2 months&#xD;
&#xD;
        -  SCORAD / PO SCORAD&#xD;
&#xD;
        -  Treatment weighing&#xD;
&#xD;
      Day 90:&#xD;
&#xD;
        -  SCORAD / PO-SCORAD&#xD;
&#xD;
        -  Treatments weighing&#xD;
&#xD;
        -  Remitting the final questionnaire&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 14, 2014</start_date>
  <completion_date type="Actual">October 31, 2015</completion_date>
  <primary_completion_date type="Actual">September 30, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Assess the feasibility of giving the choice to the patient/parent of different galenic in atopic dermatitis.</measure>
    <time_frame>90 days</time_frame>
    <description>Assess the feasibility of giving the choice to the patient/parent of different galenic in atopic dermatitis.&#xD;
The primary outcome is evaluated through a questionnaire given to the patient/parent at day 0 day 30 day 90.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate the impact of this procedure in patient adherence to treatment (trough weighing treatments at day 30 and day 90)</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the impact of this procedure on the evolution of the disease</measure>
    <time_frame>90 days</time_frame>
    <description>Evaluate the impact of this procedure on the evolution of the disease (trough SCORAD and PO-SCORAD at day 0, day 30, day 90)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess the feasibility point of view of the prescribing physician</measure>
    <time_frame>90 days</time_frame>
    <description>- Assess the feasibility point of view of the prescribing physician (through questionnaires at day 0 day 30 day 90)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measuring the characteristics of a specified product and those of a product chosen by the patient</measure>
    <time_frame>90 days</time_frame>
    <description>- 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)</description>
  </secondary_outcome>
  <enrollment type="Actual">24</enrollment>
  <condition>Atopic Dermatitis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Multicenter prospective nonrandomized uncontrolled open-label study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients experiencing treatment failure despite appropriate treatment. Patients minors aged&#xD;
        between 3 and 15 years For children age 7 and non-autonomous children in the application of&#xD;
        treatment, the parent at the initial consultation should be the one who treats the child.&#xD;
&#xD;
        Information from both parents or parental authority and collection of Non-Opposition The&#xD;
        patient must have a computer to do its PO-SCORAD between consultations. Patient who used a&#xD;
        topical treatment for atopic dermatitis in the week preceding the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patient refusal to participate in the clinical study. Adults and children over 15 years.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-François Stalder, PU-PH</last_name>
    <role>Study Director</role>
    <affiliation>CHU de Nantes</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jean-Marc Chavigny, PH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Pasteur Dermatologie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Nantes</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>http://www.decas.univ-nantes.fr/GET/GET/POSCORAD_files/Po-Scorad_FR.pdf</url>
    <description>PO SCORAD</description>
  </link>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>September 14, 2021</last_update_submitted>
  <last_update_submitted_qc>September 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atopic dermatitis, Feasibility, Adherence to treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Eczema</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02193230
org study id: RC14_0073
nct id: NCT02193230
lead sponsor: 
has dmc: No
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.
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
observational model: Other
time perspective: Prospective
measure: Assess the feasibility of giving the choice to the patient/parent of different galenic in atopic dermatitis.
time frame: 90 days
description: 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.
measure: Evaluate the impact of this procedure in patient adherence to treatment (trough weighing treatments at day 30 and day 90)
time frame: 90 days
measure: Evaluate the impact of this procedure on the evolution of the disease
time frame: 90 days
description: Evaluate the impact of this procedure on the evolution of the disease (trough SCORAD and PO-SCORAD at day 0, day 30, day 90)
measure: Assess the feasibility point of view of the prescribing physician
time frame: 90 days
description: - Assess the feasibility point of view of the prescribing physician (through questionnaires at day 0 day 30 day 90)
measure: Measuring the characteristics of a specified product and those of a product chosen by the patient
time frame: 90 days
description: - 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)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: 15 Years
healthy volunteers: No
last name: Jean-François Stalder, PU-PH
role: Study Director
affiliation: CHU de Nantes
last name: Jean-Marc Chavigny, PH
role: Principal Investigator
affiliation: Centre Pasteur Dermatologie
facility: 
country: France
url: http://www.decas.univ-nantes.fr/GET/GET/POSCORAD_files/Po-Scorad_FR.pdf
description: PO SCORAD
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema