xml: <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/NCT05979506</url>
    </required_header>
    <id_info>
      <org_study_id>RC31/21/0341</org_study_id>
      <nct_id>NCT05979506</nct_id>
    </id_info>
    <brief_title>Evaluate the Evolution of Body and Scalp Skin Discomfort in Patients With Hereditary Ichthyosis After Wraps (EnvelopIchtyose)</brief_title>
    <official_title>Evaluate the Evolution of Cutaneous Discomfort of the Body and Scalp After 3 Wraps, in Patients With Moderate to Very Severe Hereditary Ichthyosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Toulouse</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Toulouse</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>
        Ichthyosis is a group of rare and chronic genetic diseases beginning at birth, in which the&#xD;
        patient's skin is covered with scales of variable appearance and severity. This disease is&#xD;
        disabling, in particular due to sensations of pruritus, skin pain and the possible presence&#xD;
        of associated extra-cutaneous abnormalities. The treatment is symptomatic and is based on the&#xD;
        daily application of moisturizing creams with a high lipid content for better effectiveness,&#xD;
        keratolytic creams, and for severe forms, oral retinoids may be necessary. Nevertheless, the&#xD;
        effectiveness of these treatments is limited and are considered very painful by the patients.&#xD;
        Wraps are local treatments carried out by specialized nurses and which consist in, following&#xD;
        a therapeutic bath, applying a large quantity of cream to the whole body, followed by an&#xD;
        occlusion. This type of care is simple to perform, but requires nursing expertise, to date,&#xD;
        it is not carried out in standard practice in France, which is why we wish to evaluate the&#xD;
        effect of wraps on different parameters reflecting the skin condition in the short and medium&#xD;
        term.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Ichthyosis is a group of rare and chronic genetic diseases beginning at birth, in which the&#xD;
        patient's skin is covered with scales of variable appearance and severity. There are 2&#xD;
        distinct typical profiles: patients with thick scales without erythroderma and patients with&#xD;
        finer scales on an erythrodermic background. This disease is disabling, in particular due to&#xD;
        sensations of pruritus, skin pain and the possible presence of associated extra-cutaneous&#xD;
        abnormalities. The treatment is symptomatic and is based on the daily application of&#xD;
        moisturizing creams with a high lipid content for better effectiveness, keratolytic creams,&#xD;
        and for severe forms, oral retinoids may be necessary. The creams improve the condition of&#xD;
        the skin and reduce the sensations of skin discomfort, pain and pruritus, nevertheless, the&#xD;
        effectiveness of these treatments is limited and are considered very painful by the patients.&#xD;
  &#xD;
        Wraps are local treatments carried out by specialized nurses and which consist in, following&#xD;
        a therapeutic bath, applying a large quantity of cream to the whole body, followed by an&#xD;
        occlusion. The type of cream is adapted to the area of application: thus, an emollient cream&#xD;
        is used for the body; a cream enriched with keratolytic active ingredients is used for the&#xD;
        feet in the event of hyperkeratosis, and an emollient cream possibly enriched with&#xD;
        keratolytic active ingredients is used for the scalp, followed by an exposure time under a&#xD;
        steam helmet to remove scales. This type of care is simple to perform, but requires nursing&#xD;
        expertise, to date, it is not carried out in standard practice in France, except in the&#xD;
        centers of Toulouse, Bordeaux and Necker and at the thermal cure of Avène-les-Bains. However,&#xD;
        the interest of such a treatment has never been evaluated independently, which is why in this&#xD;
        study we want to evaluate the effect of carrying out a daily treatment (including a&#xD;
        therapeutic bath, a wrap (body and feet) and scalp care) over 3 consecutive days, on&#xD;
        different parameters reflecting the skin condition in the short and medium term&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">April 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">April 1, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Interventional, prospective, multicenter (Toulouse - Bordeaux - Paris Necker), comparative (baseline vs. short and medium term)</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Skin discomfort Analogue Visual Scale (AVS)</measure>
      <time_frame>day 11</time_frame>
      <description>Percentage of patients showing a reduction of at least 3 points of their skin discomfort in the entire body, measured with the AVS scale (0-10) of cutaneous discomfort between baseline and 11 days after treatment</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Reduction of skin discomfort - day 4</measure>
      <time_frame>day 4</time_frame>
      <description>Percentage of patients showing a reduction of at least 3 points of their skin discomfort in the entire body, measured with the Analogue Visual Scale (AVS) (0-10) of cutaneous discomfort between baseline and day 4</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Reduction of skin discomfort - day 30</measure>
      <time_frame>day 30</time_frame>
      <description>Percentage of patients showing a reduction of at least 3 points of their skin discomfort in the entire body, measured with the Analogue Visual Scale (AVS) (0-10) of cutaneous discomfort between baseline and day 30</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Variation of erythema and scales severity - VIIS</measure>
      <time_frame>day 4</time_frame>
      <description>Variation of erythema and scales severity judged by :&#xD;
  - Their intensity, measured with the Visual Index for Ichthyosis Severity (VIIS)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Variation of erythema and scales severity</measure>
      <time_frame>day 4</time_frame>
      <description>Variation of erythema and scales severity judged by :&#xD;
  -Their extent, measured with the scores A and B of the Specific Clinical Ichthyosis Score</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cutaneous pain - day 4</measure>
      <time_frame>day 4</time_frame>
      <description>Variation of pain assessed by the Analogue Visual Scale (0-10) of skin pain</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>pruritus - day 4</measure>
      <time_frame>day 4</time_frame>
      <description>Variation of pruritus assessed by the Analogue Visual Scale (0-10)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>sweating - day 4</measure>
      <time_frame>day 4</time_frame>
      <description>Variation of sweating assessed by the Analogue Visual Scale (0-10)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cutaneous pain - day 11</measure>
      <time_frame>day 11</time_frame>
      <description>Variation of pain assessed by the Analogue Visual scale (0-10) of skin pain</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>pruritus - day 11</measure>
      <time_frame>day 11</time_frame>
      <description>Variation of pruritus assessed by the Analogue Visual scale (0-10)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>sweating - day 11</measure>
      <time_frame>day 11</time_frame>
      <description>Variation of sweating assessed by the Analogue Visual Scale scale (0-10)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cutaneous pain - day 30</measure>
      <time_frame>day 30</time_frame>
      <description>Variation of pain assessed by the Analogue Visual Scale (0-10) of skin pain</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>pruritus - day 30</measure>
      <time_frame>day 30</time_frame>
      <description>Variation of pruritus assessed by the Analogue Visual Scale scale (0-10)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>sweating - day 30</measure>
      <time_frame>day 30</time_frame>
      <description>Variation of sweating assessed by the Analogue Visual Scale (0-10)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Feet and scalp discomfort - day 4</measure>
      <time_frame>day 4</time_frame>
      <description>Percentage of patients showing a reduction of at least 3 points of their skin discomfort in the feet and scalp, measured with the Analogue Visual Scale (0-10) of cutaneous discomfort</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Feet and scalp discomfort - day 11</measure>
      <time_frame>day 11</time_frame>
      <description>Percentage of patients showing a reduction of at least 3 points of their skin discomfort in the feet and scalp, measured with the Analogue Visual Scale (0-10) of cutaneous discomfort</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Feet and scalp discomfort - day 30</measure>
      <time_frame>day 30</time_frame>
      <description>Percentage of patients showing a reduction of at least 3 points of their skin discomfort in the feet and scalp, measured with the Analogue Visual Scale (0-10) of cutaneous discomfort</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>32-item Ichthyosis Quality of Life questionnaire (IQoL-32)</measure>
      <time_frame>30 days after treatment</time_frame>
      <description>Variation of patient's quality of life, measured by the ichthyosis specific quality of life questionnaire (IQoL-32)</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">34</enrollment>
    <condition>Ichthyosis Inherited</condition>
    <arm_group>
      <arm_group_label>Wraps (body and feet) as well as scalp care</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The skin care consisting of wraps (body and feet) and scalp care, will be carried out consecutively over 3 days, in the hospital (outpatient or in day/traditional hospitalization).</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Cutaneous wraps</intervention_name>
      <description>The topical treatment that will be used in this study are:&#xD;
  For the body, an emollient cream with a high lipid content: Cold cream&#xD;
  For the scalp and feet, an emollient preparation with keratolytic action: 10% or 30% urea, depending on the scalp and feet damage&#xD;
  Each of the 3 treatments (body, scalp and feet) will be carried out as follows:&#xD;
  Application of different topicals all over the body and face, after taking a lukewarm therapeutic bath of 20 minutes&#xD;
  Occlusion by &quot;wrapping&quot; the patient in a plastic film, then covering with a blanket&#xD;
  After 1 hour, the unabsorbed excess cream is removed with a towel</description>
      <arm_group_label>Wraps (body and feet) as well as scalp care</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient with hereditary ichthyosis regardless of the clinical form&#xD;
  &#xD;
            -  Patient with a scaling or erythema score &gt; 6/16&#xD;
  &#xD;
            -  Patient with a skin discomfort score &gt; 3/10&#xD;
  &#xD;
            -  Patient having given written, free and informed consent&#xD;
  &#xD;
            -  Patient affiliated to a social security scheme&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient with a skin disease other than ichthyosis&#xD;
  &#xD;
            -  Patient having modified his treatments for ichthyosis in the month preceding inclusion&#xD;
  &#xD;
            -  Patient with known intolerance or allergy to one of the topicals used in the study&#xD;
  &#xD;
            -  Patient unable to complete the study questionnaires&#xD;
  &#xD;
            -  Patient under a protection regime&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Anne-Marie TRANIER</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital, Toulouse</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Anne-Marie TRANIER</last_name>
      <phone>05 67 77 14 57</phone>
      <email>tranier.am@chu-toulouse.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Toulouse University hospital</name>
        <address>
          <city>Toulouse</city>
          <zip>31059</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Anne-Marie TRANIER</last_name>
        <phone>0567771457</phone>
        <email>tranier.am@chu-toulouse.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Ichthyosis</keyword>
    <keyword>inherited</keyword>
    <keyword>wraps</keyword>
    <keyword>skin scales</keyword>
    <keyword>cutaneous abnormalities</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ichthyosis</mesh_term>
      <mesh_term>Ichthyosis, Lamellar</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05979506
  org study id: RC31/21/0341
  nct id: NCT05979506
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Ichthyosis is a group of rare and chronic genetic diseases beginning at birth, in which the
        patient's skin is covered with scales of variable appearance and severity. This disease is
        disabling, in particular due to sensations of pruritus, skin pain and the possible presence
        of associated extra-cutaneous abnormalities. The treatment is symptomatic and is based on the
        daily application of moisturizing creams with a high lipid content for better effectiveness,
        keratolytic creams, and for severe forms, oral retinoids may be necessary. Nevertheless, the
        effectiveness of these treatments is limited and are considered very painful by the patients.
        Wraps are local treatments carried out by specialized nurses and which consist in, following
        a therapeutic bath, applying a large quantity of cream to the whole body, followed by an
        occlusion. This type of care is simple to perform, but requires nursing expertise, to date,
        it is not carried out in standard practice in France, which is why we wish to evaluate the
        effect of wraps on different parameters reflecting the skin condition in the short and medium
        term.
  Ichthyosis is a group of rare and chronic genetic diseases beginning at birth, in which the
        patient's skin is covered with scales of variable appearance and severity. There are 2
        distinct typical profiles: patients with thick scales without erythroderma and patients with
        finer scales on an erythrodermic background. This disease is disabling, in particular due to
        sensations of pruritus, skin pain and the possible presence of associated extra-cutaneous
        abnormalities. The treatment is symptomatic and is based on the daily application of
        moisturizing creams with a high lipid content for better effectiveness, keratolytic creams,
        and for severe forms, oral retinoids may be necessary. The creams improve the condition of
        the skin and reduce the sensations of skin discomfort, pain and pruritus, nevertheless, the
        effectiveness of these treatments is limited and are considered very painful by the patients.
  
        Wraps are local treatments carried out by specialized nurses and which consist in, following
        a therapeutic bath, applying a large quantity of cream to the whole body, followed by an
        occlusion. The type of cream is adapted to the area of application: thus, an emollient cream
        is used for the body; a cream enriched with keratolytic active ingredients is used for the
        feet in the event of hyperkeratosis, and an emollient cream possibly enriched with
        keratolytic active ingredients is used for the scalp, followed by an exposure time under a
        steam helmet to remove scales. This type of care is simple to perform, but requires nursing
        expertise, to date, it is not carried out in standard practice in France, except in the
        centers of Toulouse, Bordeaux and Necker and at the thermal cure of Avène-les-Bains. However,
        the interest of such a treatment has never been evaluated independently, which is why in this
        study we want to evaluate the effect of carrying out a daily treatment (including a
        therapeutic bath, a wrap (body and feet) and scalp care) over 3 consecutive days, on
        different parameters reflecting the skin condition in the short and medium term
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Interventional, prospective, multicenter (Toulouse - Bordeaux - Paris Necker), comparative (baseline vs. short and medium term)
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Skin discomfort Analogue Visual Scale (AVS)
  time frame: day 11
  description: Percentage of patients showing a reduction of at least 3 points of their skin discomfort in the entire body, measured with the AVS scale (0-10) of cutaneous discomfort between baseline and 11 days after treatment
  measure: Reduction of skin discomfort - day 4
  time frame: day 4
  description: Percentage of patients showing a reduction of at least 3 points of their skin discomfort in the entire body, measured with the Analogue Visual Scale (AVS) (0-10) of cutaneous discomfort between baseline and day 4
  measure: Reduction of skin discomfort - day 30
  time frame: day 30
  description: Percentage of patients showing a reduction of at least 3 points of their skin discomfort in the entire body, measured with the Analogue Visual Scale (AVS) (0-10) of cutaneous discomfort between baseline and day 30
  measure: Variation of erythema and scales severity - VIIS
  time frame: day 4
  description: Variation of erythema and scales severity judged by :
  - Their intensity, measured with the Visual Index for Ichthyosis Severity (VIIS)
  measure: Variation of erythema and scales severity
  time frame: day 4
  description: Variation of erythema and scales severity judged by :
  -Their extent, measured with the scores A and B of the Specific Clinical Ichthyosis Score
  measure: Cutaneous pain - day 4
  time frame: day 4
  description: Variation of pain assessed by the Analogue Visual Scale (0-10) of skin pain
  measure: pruritus - day 4
  time frame: day 4
  description: Variation of pruritus assessed by the Analogue Visual Scale (0-10)
  measure: sweating - day 4
  time frame: day 4
  description: Variation of sweating assessed by the Analogue Visual Scale (0-10)
  measure: Cutaneous pain - day 11
  time frame: day 11
  description: Variation of pain assessed by the Analogue Visual scale (0-10) of skin pain
  measure: pruritus - day 11
  time frame: day 11
  description: Variation of pruritus assessed by the Analogue Visual scale (0-10)
  measure: sweating - day 11
  time frame: day 11
  description: Variation of sweating assessed by the Analogue Visual Scale scale (0-10)
  measure: Cutaneous pain - day 30
  time frame: day 30
  description: Variation of pain assessed by the Analogue Visual Scale (0-10) of skin pain
  measure: pruritus - day 30
  time frame: day 30
  description: Variation of pruritus assessed by the Analogue Visual Scale scale (0-10)
  measure: sweating - day 30
  time frame: day 30
  description: Variation of sweating assessed by the Analogue Visual Scale (0-10)
  measure: Feet and scalp discomfort - day 4
  time frame: day 4
  description: Percentage of patients showing a reduction of at least 3 points of their skin discomfort in the feet and scalp, measured with the Analogue Visual Scale (0-10) of cutaneous discomfort
  measure: Feet and scalp discomfort - day 11
  time frame: day 11
  description: Percentage of patients showing a reduction of at least 3 points of their skin discomfort in the feet and scalp, measured with the Analogue Visual Scale (0-10) of cutaneous discomfort
  measure: Feet and scalp discomfort - day 30
  time frame: day 30
  description: Percentage of patients showing a reduction of at least 3 points of their skin discomfort in the feet and scalp, measured with the Analogue Visual Scale (0-10) of cutaneous discomfort
  measure: 32-item Ichthyosis Quality of Life questionnaire (IQoL-32)
  time frame: 30 days after treatment
  description: Variation of patient's quality of life, measured by the ichthyosis specific quality of life questionnaire (IQoL-32)
  arm group label: Wraps (body and feet) as well as scalp care
  arm group type: Experimental
  description: The skin care consisting of wraps (body and feet) and scalp care, will be carried out consecutively over 3 days, in the hospital (outpatient or in day/traditional hospitalization).
  intervention type: Procedure
  intervention name: Cutaneous wraps
  description: The topical treatment that will be used in this study are:
  For the body, an emollient cream with a high lipid content: Cold cream
  For the scalp and feet, an emollient preparation with keratolytic action: 10% or 30% urea, depending on the scalp and feet damage
  Each of the 3 treatments (body, scalp and feet) will be carried out as follows:
  Application of different topicals all over the body and face, after taking a lukewarm therapeutic bath of 20 minutes
  Occlusion by "wrapping" the patient in a plastic film, then covering with a blanket
  After 1 hour, the unabsorbed excess cream is removed with a towel
  arm group label: Wraps (body and feet) as well as scalp care
  criteria: 
  gender: All
  minimum age: 15 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Anne-Marie TRANIER
  role: Principal Investigator
  affiliation: University Hospital, Toulouse
  last name: Anne-Marie TRANIER
  phone: 05 67 77 14 57
  email: tranier.am@chu-toulouse.fr
  facility: 
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Ichthyosis
  mesh term: Ichthyosis, Lamellar
  sharing ipd: No