<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/NCT01689805</url>
  </required_header>
  <id_info>
    <org_study_id>FLG-255-AR</org_study_id>
    <nct_id>NCT01689805</nct_id>
  </id_info>
  <brief_title>Clinical Importance of Filaggrin Gene Mutation for Treatment Outcome in Atopic Dermatitis</brief_title>
  <official_title>Do Mutations in the Filaggrin Gene Have Clinical Importance for the Treatment Outcome in Atopic Dermatitis?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helsinki University Central Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Helsinki University Central Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Atopic dermatitis is a common disease which affects about one million people in Finland at&#xD;
      some stage of their life. In atopic dermatitis we see a superficial inflammation of the skin&#xD;
      and a defect in skin barrier function. The filaggrin protein plays a central role in the skin&#xD;
      barrier function and studies indicate that about 30% of patients with atopic dermatitis have&#xD;
      a mutation in the filaggrin gene. The aim of the study is to investigate whether a mutation&#xD;
      in the filaggrin gene affects the clinical treatment outcome in patients with atopic&#xD;
      dermatitis. If a mutation predisposes to a worse response to treatment, this could be&#xD;
      examined and those patients with the mutation could be given extra treatment support for&#xD;
      their atopic dermatitis. The prevalence of filaggrin mutation in the Finnish non-atopic&#xD;
      population is studied in the control group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2011</start_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Filaggrin mutation</measure>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response to treatment</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum IgE</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">800</enrollment>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>Patients with atopic dermatitis</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-atopic controls</arm_group_label>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum samples are collected to investigate if the patient has a mutation in the filaggrin&#xD;
      gene.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with atopic dermatitis who are followed-up at the Skin and Allergy Hospital in&#xD;
        Helsinki for at least one year can be included in the study.&#xD;
&#xD;
        The control population consists of non-atopic persons without any other skin disease&#xD;
        (samples for the control population are applied for from a sample collection of the&#xD;
        National institute for health and welfare).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria (patients with atopic dermatitis):&#xD;
&#xD;
          -  Age at least 18 years&#xD;
&#xD;
          -  Clinical diagnosis of atopic dermatitis&#xD;
&#xD;
          -  Need for follow-up at the Skin and Allergy Hospital&#xD;
&#xD;
          -  Patient gives signed informed consent to participate in this study&#xD;
&#xD;
          -  Patients parents and grandparents are of Finnish origin&#xD;
&#xD;
        Inclusion Criteria (Controls):&#xD;
&#xD;
          -  No history of atopy or skin disease&#xD;
&#xD;
          -  Age at least 18 years&#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>Anita Remitz, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Skin and Allergy Hospital, Helsinki University Central Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anita Remitz, MD, PhD</last_name>
    <phone>+358-9-4711</phone>
    <email>anita.remitz@hus.fi</email>
  </overall_contact>
  <location>
    <facility>
      <name>Skin and Allergy Hospital, Departments of Dermatology and Clinical Genetics</name>
      <address>
        <city>Helsinki</city>
        <zip>PB 160</zip>
        <country>Finland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anita Remitz, MD, PhD</last_name>
      <email>anita.remitz@hus.fi</email>
    </contact>
    <investigator>
      <last_name>Anita Remitz, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sakari Reitamo, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Johanna M Mandelin, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ville Kiiski, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Minna Pöyhönen, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Eveliina Salminen, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sirpa Kivirikko, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>June 23, 2011</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>September 18, 2012</last_update_submitted>
  <last_update_submitted_qc>September 18, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 21, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Helsinki University Central Hospital</investigator_affiliation>
    <investigator_full_name>Anita Remitz</investigator_full_name>
    <investigator_title>MD, PhD, Specialist in Dermatology</investigator_title>
  </responsible_party>
  <keyword>Atopic dermatitis</keyword>
  <keyword>Filaggrin</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/NCT01689805
org study id: FLG-255-AR
nct id: NCT01689805
lead sponsor: 
has dmc: No
Atopic dermatitis is a common disease which affects about one million people in Finland at
      some stage of their life. In atopic dermatitis we see a superficial inflammation of the skin
      and a defect in skin barrier function. The filaggrin protein plays a central role in the skin
      barrier function and studies indicate that about 30% of patients with atopic dermatitis have
      a mutation in the filaggrin gene. The aim of the study is to investigate whether a mutation
      in the filaggrin gene affects the clinical treatment outcome in patients with atopic
      dermatitis. If a mutation predisposes to a worse response to treatment, this could be
      examined and those patients with the mutation could be given extra treatment support for
      their atopic dermatitis. The prevalence of filaggrin mutation in the Finnish non-atopic
      population is studied in the control group.
observational model: Case-Control
time perspective: Prospective
measure: Filaggrin mutation
measure: Response to treatment
time frame: 12 months
measure: Serum IgE
time frame: 12 months
arm group label: Patients with atopic dermatitis
arm group label: Non-atopic controls
Serum samples are collected to investigate if the patient has a mutation in the filaggrin
      gene.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anita Remitz, MD, PhD
role: Principal Investigator
affiliation: Skin and Allergy Hospital, Helsinki University Central Hospital
last name: Anita Remitz, MD, PhD
phone: +358-9-4711
email: anita.remitz@hus.fi
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: Helsinki University Central Hospital
investigator full name: Anita Remitz
investigator title: MD, PhD, Specialist in Dermatology
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema