<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/NCT02226068</url>
  </required_header>
  <id_info>
    <org_study_id>CsAvsECP-AUH</org_study_id>
    <secondary_id>CsA-ECP</secondary_id>
    <nct_id>NCT02226068</nct_id>
  </id_info>
  <brief_title>Photophoresis Versus Ciclosporine in Severe Atopic Dermatitis</brief_title>
  <official_title>Ciclosporine and Extracorporal Photopheresis (ECP) Are Equipotent in Treating Severe Atopic Dermatitis (AD): A Randomized Cross-over Study Comparing Two Efficient Treatment Modalities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Severe atopic dermatitis (AD) is a recurrent and debilitating disease often requiring&#xD;
      systemic immunosuppressive treatment. The efficacy of cyclosporine A (CsA) is well proven but&#xD;
      potential side effects are concerning. Several reports point at extracorporeal photopheresis&#xD;
      (ECP) as an efficient alternative treatment modality with few and mild side effects. However,&#xD;
      no direct comparison between CsA and ECP in the treatment of AD has been performed so far. In&#xD;
      this trial we test the hypothesis that ECP is non-inferior to standard treatment with CsA.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2002</start_date>
  <completion_date type="Actual">January 2004</completion_date>
  <primary_completion_date type="Actual">August 2003</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
  </study_design_info>
  <primary_outcome>
    <measure>Change of SCORAD (SCORing Atopic Dermatitis)</measure>
    <time_frame>4 month</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>CsA-ECP</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Sequence of therapy: First ciclosporin was given and after relapse extra corporal photopheresis was given</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ECP-CsA</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Sequence of therapy: First extra corporal photopheresis was given and after relapse ciclosporin was given</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclosporine A (CsA)</intervention_name>
    <description>3 mg/kg/day for 4 month</description>
    <arm_group_label>CsA-ECP</arm_group_label>
    <arm_group_label>ECP-CsA</arm_group_label>
    <other_name>Sandimmune</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Extracorporeal photopheresis (ECP)</intervention_name>
    <description>Administered two consecutive days twice a month for 4 month</description>
    <arm_group_label>CsA-ECP</arm_group_label>
    <arm_group_label>ECP-CsA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Criteria of inclusion were refractoriness to standard topical treatment (corticosteroid&#xD;
        ointments, UVA, UVB, PUVA, tar).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Criteria of exclusion were pregnancy, uncontrolled hypertension, previous malignancy,&#xD;
        infectious disease, liver/kidney disease or active treatment with ECP or immunosuppressants&#xD;
        within 4 weeks prior to start of trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Erik Obitz, MD, DMSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark</affiliation>
  </overall_official>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <last_update_submitted>March 26, 2015</last_update_submitted>
  <last_update_submitted_qc>March 26, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 27, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atopic dermatitis</keyword>
  <keyword>Ciclosporine</keyword>
  <keyword>Extracorporal photopheresis</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cyclosporine</mesh_term>
    <mesh_term>Cyclosporins</mesh_term>
  </intervention_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/NCT02226068
org study id: CsAvsECP-AUH
secondary id: CsA-ECP
nct id: NCT02226068
lead sponsor: 
has dmc: No
Severe atopic dermatitis (AD) is a recurrent and debilitating disease often requiring
      systemic immunosuppressive treatment. The efficacy of cyclosporine A (CsA) is well proven but
      potential side effects are concerning. Several reports point at extracorporeal photopheresis
      (ECP) as an efficient alternative treatment modality with few and mild side effects. However,
      no direct comparison between CsA and ECP in the treatment of AD has been performed so far. In
      this trial we test the hypothesis that ECP is non-inferior to standard treatment with CsA.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
measure: Change of SCORAD (SCORing Atopic Dermatitis)
time frame: 4 month
arm group label: CsA-ECP
arm group type: Other
description: Sequence of therapy: First ciclosporin was given and after relapse extra corporal photopheresis was given
arm group label: ECP-CsA
arm group type: Other
description: Sequence of therapy: First extra corporal photopheresis was given and after relapse ciclosporin was given
intervention type: Drug
intervention name: Cyclosporine A (CsA)
description: 3 mg/kg/day for 4 month
arm group label: CsA-ECP
arm group label: ECP-CsA
other name: Sandimmune
intervention type: Other
intervention name: Extracorporeal photopheresis (ECP)
description: Administered two consecutive days twice a month for 4 month
arm group label: CsA-ECP
arm group label: ECP-CsA
criteria: 
gender: All
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: No
last name: Erik Obitz, MD, DMSc
role: Principal Investigator
affiliation: Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
mesh term: Cyclosporine
mesh term: Cyclosporins