<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/NCT03023254</url>
  </required_header>
  <id_info>
    <org_study_id>PAP</org_study_id>
    <nct_id>NCT03023254</nct_id>
  </id_info>
  <brief_title>An Exploratory Study to Assess the Efficacy of the Avène Hydrotherapy</brief_title>
  <acronym>PAP</acronym>
  <official_title>An Exploratory Study to Assess the Efficacy of the Avène Hydrotherapy on Chronic Pruritus in Adults With Plaque Psoriasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pierre Fabre Dermo Cosmetique</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pierre Fabre Dermo Cosmetique</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess the benefit of the Avène hydrotherapy in subjects with pruritic plaque psoriasis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  To assess the benefit of the Avène hydrotherapy in subjects with pruritic plaque&#xD;
           psoriasis in the:&#xD;
&#xD;
             -  Improvement of pruritus&#xD;
&#xD;
             -  Improvement of psoriasis severity&#xD;
&#xD;
             -  Improvement of quality of life&#xD;
&#xD;
             -  Change of pruritus and psoriasis biological markers&#xD;
&#xD;
             -  Intake/application of treatments and skin care products for psoriasis and pruritus&#xD;
                management, evaluated during a follow-up period&#xD;
&#xD;
        -  To assess the time to pruritus relapse evaluated in subjects with pruritic plaque&#xD;
           psoriasis, during the period following the Avène hydrotherapy (for the hydrotherapy&#xD;
           group only)&#xD;
&#xD;
        -  To assess the global efficacy of the Avène hydrotherapy in pruritic plaque psoriasis,&#xD;
           according to subjects' and investigators' opinion (for the hydrotherapy group only)&#xD;
&#xD;
        -  To assess the global cutaneous tolerance of the Avène hydrotherapy in subjects with&#xD;
           pruritic plaque psoriasis (for the hydrotherapy group only)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 6, 2017</start_date>
  <completion_date type="Actual">July 20, 2020</completion_date>
  <primary_completion_date type="Actual">July 20, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pruritus clinical criterion</measure>
    <time_frame>Day18</time_frame>
    <description>Pruritus intensity assessed by the subject on the NRS from 0 to 10</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pruritus clinical criterion</measure>
    <time_frame>Day1</time_frame>
    <description>Pruritus intensity assessed by the subject on the NRS from 0 to 10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pruritus clinical criterion</measure>
    <time_frame>Day111</time_frame>
    <description>Pruritus intensity assessed by the subject on the NRS from 0 to 10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pruritus clinical criterion</measure>
    <time_frame>Day202</time_frame>
    <description>Pruritus intensity assessed by the subject on the NRS from 0 to 10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psoriasis clinical criterion</measure>
    <time_frame>Day1, Day18, Day111 and Day202</time_frame>
    <description>Psoriasis Area Severity Index assessed by the investigator on a scale ranged from 0 to 72</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life criterion</measure>
    <time_frame>Day1, Day18, Day111 and Day202</time_frame>
    <description>ItchyQoL questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biological criterion (markers linked to neurogenic inflammation, epidermal differentiation, inflammation, antimicrobial peptides)</measure>
    <time_frame>Day1, Day18, Day111 and Day202</time_frame>
    <description>Psoriasis and pruritus biological markers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hydrotherapy criterion</measure>
    <time_frame>Day18</time_frame>
    <description>Hydrotherapy global cutaneous tolerance on 4-point scale (0 = No effective ; 1=Little effective ; 2=Effective and 3=Very effective)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Chronic Pruritus Due to Plaque Psoriasis</condition>
  <arm_group>
    <arm_group_label>hydrotherapy group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects included in the &quot;hydrotherapy group&quot; will undergo a 3-week Avène hydrotherapy in addition to their usual psoriasis and/or pruritus management (treatments and/or skin care products).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects included in the &quot;control group&quot; will not undergo the hydrotherapy and will keep following their usual psoriasis and/or pruritus management (treatments and/or skin care products).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hydrotherapy</intervention_name>
    <description>3-week Avène hydrotherapy</description>
    <arm_group_label>hydrotherapy group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject with plaque psoriasis&#xD;
&#xD;
          -  Subject with moderate to very severe chronic pruritus whose NRS score ≥ 4, (on a scale&#xD;
             ranged from 0 to 10)&#xD;
&#xD;
          -  Subject with chronic pruritus, i.e. for at least 6 weeks, due to plaque psoriasis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject with erythrodermic psoriasis, pustular psoriasis or palmoplantar keratoderma&#xD;
&#xD;
          -  Subject with any other type of pruritus, not related to plaque psoriasis&#xD;
&#xD;
          -  Subject with an acute, chronic or progressive disease other than plaque psoriasis&#xD;
             which could be the origin of the pruritus&#xD;
&#xD;
          -  Biotherapy, Phototherapy or PUVAtherapy treatment&#xD;
&#xD;
          -  Psoriasis treatment by LASER&#xD;
&#xD;
          -  Systemic or topical treatment taken/applied for psoriasis or pruritus management&#xD;
             established or modified since the selection visit or planned to be established or&#xD;
             modified between the inclusion visit and the end of the hydrotherapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Diana PLACINTESCU, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Les Thermes d'Avène</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Nord Service de Dermatologie</name>
      <address>
        <city>Amiens</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Angers Service de Dermatologie</name>
      <address>
        <city>Angers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Martins-Hericher</name>
      <address>
        <city>Angers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH de Boulogne sur Mer Hôpital DUCHENE - service de dermatologie</name>
      <address>
        <city>Boulogne-sur-Mer</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Morvan service de dermatologie</name>
      <address>
        <city>Brest</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Durbise</name>
      <address>
        <city>Cahors</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Parant</name>
      <address>
        <city>Clisson</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Dunkerque - Service de Dermatologie</name>
      <address>
        <city>Dunkerque</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Abbadie</name>
      <address>
        <city>Langon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Durieu</name>
      <address>
        <city>Lavaur</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Orsoni</name>
      <address>
        <city>Limoges</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Gutmann Heller</name>
      <address>
        <city>Lingolsheim</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Foucault</name>
      <address>
        <city>Lorient</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Nicol</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Ruer-Mulard</name>
      <address>
        <city>Martigues</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital St Eloi Service de Dermatologie</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GHRMSA Hôpital Emile Muller Service de Dermatologie</name>
      <address>
        <city>Mulhouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Nantes - Unité Dermato-Cancérologie 7° nord Hotel Dieu</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD) - Hôpital l'Archet 2</name>
      <address>
        <city>Nice</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Nice - Hôpital l'Archet 1 - Centre de recherche clinique</name>
      <address>
        <city>Nice</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Fritsch</name>
      <address>
        <city>Obernai</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Pfister</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Poitiers Pole régional de cancérologie Service de dermatologie</name>
      <address>
        <city>Poitiers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre hospitalier Poissy St germain</name>
      <address>
        <city>Saint-Germain-en-Laye</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Gadroy</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Tours Service de Dermatologie</name>
      <address>
        <city>Tours</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Abdo-Morales</name>
      <address>
        <city>Tours</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de la Santa Creu i Sant Pau Dept. of Dermatology</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Santa Caterina</name>
      <address>
        <city>Girona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Spain</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>October 25, 2016</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>April 1, 2021</last_update_submitted>
  <last_update_submitted_qc>April 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
    <mesh_term>Pruritus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03023254
org study id: PAP
nct id: NCT03023254
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To assess the benefit of the Avène hydrotherapy in subjects with pruritic plaque psoriasis
-  To assess the benefit of the Avène hydrotherapy in subjects with pruritic plaque
           psoriasis in the:

             -  Improvement of pruritus

             -  Improvement of psoriasis severity

             -  Improvement of quality of life

             -  Change of pruritus and psoriasis biological markers

             -  Intake/application of treatments and skin care products for psoriasis and pruritus
                management, evaluated during a follow-up period

        -  To assess the time to pruritus relapse evaluated in subjects with pruritic plaque
           psoriasis, during the period following the Avène hydrotherapy (for the hydrotherapy
           group only)

        -  To assess the global efficacy of the Avène hydrotherapy in pruritic plaque psoriasis,
           according to subjects' and investigators' opinion (for the hydrotherapy group only)

        -  To assess the global cutaneous tolerance of the Avène hydrotherapy in subjects with
           pruritic plaque psoriasis (for the hydrotherapy group only)
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Pruritus clinical criterion
time frame: Day18
description: Pruritus intensity assessed by the subject on the NRS from 0 to 10
measure: Pruritus clinical criterion
time frame: Day1
description: Pruritus intensity assessed by the subject on the NRS from 0 to 10
measure: Pruritus clinical criterion
time frame: Day111
description: Pruritus intensity assessed by the subject on the NRS from 0 to 10
measure: Pruritus clinical criterion
time frame: Day202
description: Pruritus intensity assessed by the subject on the NRS from 0 to 10
measure: Psoriasis clinical criterion
time frame: Day1, Day18, Day111 and Day202
description: Psoriasis Area Severity Index assessed by the investigator on a scale ranged from 0 to 72
measure: Quality of life criterion
time frame: Day1, Day18, Day111 and Day202
description: ItchyQoL questionnaire
measure: Biological criterion (markers linked to neurogenic inflammation, epidermal differentiation, inflammation, antimicrobial peptides)
time frame: Day1, Day18, Day111 and Day202
description: Psoriasis and pruritus biological markers
measure: Hydrotherapy criterion
time frame: Day18
description: Hydrotherapy global cutaneous tolerance on 4-point scale (0 = No effective ; 1=Little effective ; 2=Effective and 3=Very effective)
arm group label: hydrotherapy group
arm group type: Other
description: Subjects included in the "hydrotherapy group" will undergo a 3-week Avène hydrotherapy in addition to their usual psoriasis and/or pruritus management (treatments and/or skin care products).
arm group label: Control group
arm group type: No Intervention
description: Subjects included in the "control group" will not undergo the hydrotherapy and will keep following their usual psoriasis and/or pruritus management (treatments and/or skin care products).
intervention type: Other
intervention name: Hydrotherapy
description: 3-week Avène hydrotherapy
arm group label: hydrotherapy group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Diana PLACINTESCU, MD
role: Principal Investigator
affiliation: Les Thermes d'Avène
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country: France
country: Spain
responsible party type: Sponsor
mesh term: Psoriasis
mesh term: Pruritus
sharing ipd: No