<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/NCT03289260</url>
  </required_header>
  <id_info>
    <org_study_id>AdAM_2017</org_study_id>
    <nct_id>NCT03289260</nct_id>
  </id_info>
  <brief_title>Adjuvant Anal Imiquimod Therapy in Anal HPV-lesions: AdAM-trial</brief_title>
  <acronym>AdAM</acronym>
  <official_title>Adjuvant Imiquimod Therapy to Reduce Recurrence Rate in Patients After Surgical Therapy of Anal HPV (Human Papilloma Virus)-Lesions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University Innsbruck</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University Innsbruck</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      AdAM is a prospective, randomized, controlled, double-blinded, monocentric trial in patients&#xD;
      receiving surgical therapy due to anal HPV infection.&#xD;
&#xD;
      Aim of the study is to evaluate efficacy of combination therapy (surgical therapy + topical&#xD;
      Imiquimod-therapy). It is planned to include 200 patients.&#xD;
&#xD;
      100 patients receive surgical therapy+ topical Imiquimod therapy, 100 patients receive&#xD;
      surgical therapy + topical Placebo therapy&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">November 15, 2021</start_date>
  <completion_date type="Anticipated">November 15, 2024</completion_date>
  <primary_completion_date type="Anticipated">November 15, 2024</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in recurrence rates between the two arms</measure>
    <time_frame>12 months</time_frame>
    <description>Recurrence is evaluated by clinical examination (proctoscopy)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CD4 (cluster of differentiation 4) cell count</measure>
    <time_frame>12 months</time_frame>
    <description>Influence of CD4 cell count in the subgroup of HIV positive patients</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Anogenital Human Papillomavirus Infection</condition>
  <condition>Condyloma Anal</condition>
  <arm_group>
    <arm_group_label>Interventional Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Imiquimod 5% cream therapy Fulguration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo cream therapy Fulguration</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Imiquimod 5% cream</intervention_name>
    <description>Patients receive topical Imiquimod therapy for 12 weeks.</description>
    <arm_group_label>Interventional Arm</arm_group_label>
    <other_name>Aldara</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo cream</intervention_name>
    <description>Patients receive topical Doritin therapy for 12 weeks</description>
    <arm_group_label>Placebo Arm</arm_group_label>
    <other_name>Doritin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Fulguration</intervention_name>
    <description>Surgical Excision and Fulguration of condyloma</description>
    <arm_group_label>Interventional Arm</arm_group_label>
    <arm_group_label>Placebo Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ability to understand and willingness to sign and date a written consent document&#xD;
&#xD;
          -  Male and female patients &gt;= 18 years of age&#xD;
&#xD;
          -  Negative urine/serum pregnancy test&#xD;
&#xD;
          -  Indication for surgical therapy of anal HPV lesions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in another clinical study with experimental therapy&#xD;
&#xD;
          -  Diagnosis and therapy of HPV associated lesions in the last 12 months&#xD;
&#xD;
          -  Known intolerance of hypersensitivity to Imiquimod&#xD;
&#xD;
          -  Women who are pregnant of lactating&#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>Dietmar Öfner-Velano, MD</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital for Visceral, Transplant and Thoracic Surgery</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Irmgard E Kronberger, MD</last_name>
    <phone>0043512504</phone>
    <phone_ext>80823</phone_ext>
    <email>irmgard.kronberger@i-med.ac.at</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sascha Czipin, MD</last_name>
    <phone>0043512504</phone>
    <phone_ext>82070</phone_ext>
    <email>sascha.czipin@i-med.ac.at</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Visceral-, Transplant- and Thoracic Surgery</name>
      <address>
        <city>Innsbruck</city>
        <state>Tyrol</state>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>September 22, 2020</last_update_submitted>
  <last_update_submitted_qc>September 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University Innsbruck</investigator_affiliation>
    <investigator_full_name>Irmgard E Kronberger, MD</investigator_full_name>
    <investigator_title>Leading Consultent</investigator_title>
  </responsible_party>
  <keyword>Condylomata acuminata, Fulguration, Imiquimod</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Papillomavirus Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Imiquimod</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03289260
org study id: AdAM_2017
nct id: NCT03289260
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
AdAM is a prospective, randomized, controlled, double-blinded, monocentric trial in patients
      receiving surgical therapy due to anal HPV infection.

      Aim of the study is to evaluate efficacy of combination therapy (surgical therapy + topical
      Imiquimod-therapy). It is planned to include 200 patients.

      100 patients receive surgical therapy+ topical Imiquimod therapy, 100 patients receive
      surgical therapy + topical Placebo therapy
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Difference in recurrence rates between the two arms
time frame: 12 months
description: Recurrence is evaluated by clinical examination (proctoscopy)
measure: CD4 (cluster of differentiation 4) cell count
time frame: 12 months
description: Influence of CD4 cell count in the subgroup of HIV positive patients
arm group label: Interventional Arm
arm group type: Experimental
description: Imiquimod 5% cream therapy Fulguration
arm group label: Placebo Arm
arm group type: Placebo Comparator
description: Placebo cream therapy Fulguration
intervention type: Drug
intervention name: Imiquimod 5% cream
description: Patients receive topical Imiquimod therapy for 12 weeks.
arm group label: Interventional Arm
other name: Aldara
intervention type: Drug
intervention name: Placebo cream
description: Patients receive topical Doritin therapy for 12 weeks
arm group label: Placebo Arm
other name: Doritin
intervention type: Procedure
intervention name: Fulguration
description: Surgical Excision and Fulguration of condyloma
arm group label: Interventional Arm
arm group label: Placebo Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dietmar Öfner-Velano, MD
role: Study Director
affiliation: University Hospital for Visceral, Transplant and Thoracic Surgery
last name: Irmgard E Kronberger, MD
phone: 0043512504
phone ext: 80823
email: irmgard.kronberger@i-med.ac.at
last name: Sascha Czipin, MD
phone: 0043512504
phone ext: 82070
email: sascha.czipin@i-med.ac.at
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University Innsbruck
investigator full name: Irmgard E Kronberger, MD
investigator title: Leading Consultent
mesh term: Papillomavirus Infections
mesh term: Imiquimod
sharing ipd: Undecided