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/NCT05998291</url>
    </required_header>
    <id_info>
      <org_study_id>R23003</org_study_id>
      <nct_id>NCT05998291</nct_id>
    </id_info>
    <brief_title>Dermatitis Herpetiformis Refractory to Gluten Free Diet</brief_title>
    <official_title>Gluteenittomaan Ruokavaliohoitoon Vastaamaton Ihokeliakia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tampere University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Tampere University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Helsinki</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Tampere University Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
    </oversight_info>
    <brief_summary>
      <textblock>
        The main purpose of the study is to find out&#xD;
  &#xD;
          1. the natural course of refractory dermatitis herpetiformis and the development of&#xD;
             possible complications&#xD;
  &#xD;
          2. the strictness of gluten-free diet treatment in refractory dermatitis herpetiformis&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Refractory dermatitis herpetiformis refers to dermatitis herpetiformis unresponsive to&#xD;
        gluten-free diet therapy. So far, there is very little knowledge on the course of the disease&#xD;
        and the causes and prognosis of refractory celiac disease.&#xD;
  &#xD;
        Study patients with refractory dermatitis herpetiformis will be recruited. As a control&#xD;
        material dermatitis herpetiformis patients with good response to gluten-free dietary&#xD;
        treatment will be recruited.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">June 15, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <target_duration>1 Day</target_duration>
    <primary_outcome>
      <measure>Clinical prognosis</measure>
      <time_frame>Baseline</time_frame>
      <description>Occurrence of complications</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Dietary adherence GIP test, CDAT, TG2, TG3 and Ema antibodies, anamnesis</measure>
      <time_frame>Baseline</time_frame>
      <description>The strictness of gluten-free diet (GIP test)</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Microbiata</measure>
      <time_frame>Baseline</time_frame>
      <description>skin, oral and intestinal microbiata</description>
    </other_outcome>
    <other_outcome>
      <measure>Quality of life measure DLQI</measure>
      <time_frame>Baseline</time_frame>
      <description>DLQI (10-items, a higher score indicating lower quality of life)</description>
    </other_outcome>
    <other_outcome>
      <measure>Quality of life measure BGWP</measure>
      <time_frame>Baseline</time_frame>
      <description>PGWP (22-items with values 1-6, total score range 22-132, a higher score indicating better quality of life)</description>
    </other_outcome>
    <other_outcome>
      <measure>Gastrointestinal symptoms GSRS</measure>
      <time_frame>Baseline</time_frame>
      <description>GSRS (15 items with values 1-7, total score 1-7 as a mean value of all scores, higher score indicating more severe symptoms)</description>
    </other_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">23</enrollment>
    <condition>Dermatitis Herpetiformis</condition>
    <arm_group>
      <arm_group_label>Refractory dermatitis herpetiformis patients</arm_group_label>
      <description>Dermatitis herpetiformis rash not controlled by strict glute-free diet</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Dermatitis herpetiformis patients with good response to gluten-free diet</arm_group_label>
      <description>Dermatitis herpetiformis rash controlled by strict glute-free diet</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Assessment of prognosis of refractory dermatitis herpetiformis. No intervention</intervention_name>
      <description>Assessment of prognosis of refractory dermatitis herpetiformis. No intervention</description>
      <arm_group_label>Dermatitis herpetiformis patients with good response to gluten-free diet</arm_group_label>
      <arm_group_label>Refractory dermatitis herpetiformis patients</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adult patients with refractory dermatitis herpetiformis&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Study patients:&#xD;
  &#xD;
            -  Dermatitis herpetiformis diagnosis&#xD;
  &#xD;
            -  Dermatitis herpetiformis rash not responding to a strict gluten-free diet after at&#xD;
               least 3 years&#xD;
  &#xD;
          Control patients:&#xD;
  &#xD;
            -  Dermatitis herpetiformis diagnosis&#xD;
  &#xD;
            -  Dermatitis herpetiformis with good response to a gluten-free diet&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Study patients:&#xD;
  &#xD;
          -Not following strict gluten-free diet&#xD;
  &#xD;
          Control patients:&#xD;
  &#xD;
          -Not following a strict gluten-free diet&#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>Kaisa Hervonen, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Tampere University Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Tampere University Hospital</name>
        <address>
          <city>Tampere</city>
          <zip>33101</zip>
          <country>Finland</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Finland</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>March 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>dermatitis herpetiformis, dapsone, gluten-free diet</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dermatitis</mesh_term>
      <mesh_term>Dermatitis Herpetiformis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05998291
  org study id: R23003
  nct id: NCT05998291
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  The main purpose of the study is to find out
  
          1. the natural course of refractory dermatitis herpetiformis and the development of
             possible complications
  
          2. the strictness of gluten-free diet treatment in refractory dermatitis herpetiformis
  Refractory dermatitis herpetiformis refers to dermatitis herpetiformis unresponsive to
        gluten-free diet therapy. So far, there is very little knowledge on the course of the disease
        and the causes and prognosis of refractory celiac disease.
  
        Study patients with refractory dermatitis herpetiformis will be recruited. As a control
        material dermatitis herpetiformis patients with good response to gluten-free dietary
        treatment will be recruited.
  observational model: Case-Control
  time perspective: Cross-Sectional
  measure: Clinical prognosis
  time frame: Baseline
  description: Occurrence of complications
  measure: Dietary adherence GIP test, CDAT, TG2, TG3 and Ema antibodies, anamnesis
  time frame: Baseline
  description: The strictness of gluten-free diet (GIP test)
  measure: Microbiata
  time frame: Baseline
  description: skin, oral and intestinal microbiata
  measure: Quality of life measure DLQI
  time frame: Baseline
  description: DLQI (10-items, a higher score indicating lower quality of life)
  measure: Quality of life measure BGWP
  time frame: Baseline
  description: PGWP (22-items with values 1-6, total score range 22-132, a higher score indicating better quality of life)
  measure: Gastrointestinal symptoms GSRS
  time frame: Baseline
  description: GSRS (15 items with values 1-7, total score 1-7 as a mean value of all scores, higher score indicating more severe symptoms)
  arm group label: Refractory dermatitis herpetiformis patients
  description: Dermatitis herpetiformis rash not controlled by strict glute-free diet
  arm group label: Dermatitis herpetiformis patients with good response to gluten-free diet
  description: Dermatitis herpetiformis rash controlled by strict glute-free diet
  intervention type: Other
  intervention name: Assessment of prognosis of refractory dermatitis herpetiformis. No intervention
  description: Assessment of prognosis of refractory dermatitis herpetiformis. No intervention
  arm group label: Dermatitis herpetiformis patients with good response to gluten-free diet
  arm group label: Refractory dermatitis herpetiformis patients
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Kaisa Hervonen, PhD
  role: Principal Investigator
  affiliation: Tampere University Hospital
  facility: 
  country: Finland
  responsible party type: Sponsor
  mesh term: Dermatitis
  mesh term: Dermatitis Herpetiformis
  sharing ipd: Undecided