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/NCT06026358</url>
    </required_header>
    <id_info>
      <org_study_id>Tirbanibulin: Back of Hands</org_study_id>
      <nct_id>NCT06026358</nct_id>
    </id_info>
    <brief_title>Tirbanibulin 1% Ointment for the Treatment of Actinic Keratosis on the Back of the Hands</brief_title>
    <official_title>Tirbanibulin 1% Ointment for the Treatment of Actinic Keratosis on the Back of the Hands. An Internally Placebo Controlled, Partly Blinded Clinical Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Medical University of Graz</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Almirall, SAS</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Medical University of Graz</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>
        Interventional, monocentric, national, internal placebo-controlled, prospective pilot study,&#xD;
        consisting of two parts, A (single-blinded) and B (open) to assess Efficacy of Tirbanibulin&#xD;
        for the treatment of AK on the back of the hand. In part A, eligible subjects receive&#xD;
        Tirbanibulin on the left hand and placebo on the right hand for 5 d in a single-blinded&#xD;
        manner. Safety and efficacy are assessed at day 8 (± 1 d) (3 days after the end of treatment&#xD;
        (EoT+3) and day 57 (± 7 d) after the start of the treatment. Pictures will be taken at&#xD;
        baseline, 8 d and 57 d (± 7 d) as per protocol and optional during unscheduled visits.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Partial clearance at day 57 ± 7 after start of blinded treatment</measure>
      <time_frame>day 57 ± 7 after start of blinded treatment</time_frame>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Actinic Keratoses</condition>
    <arm_group>
      <arm_group_label>Tirbanibulin</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Treatment</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Tirbanibulin</intervention_name>
      <description>subjects receive 2,5 mgTirbanibulin in 250 mg ointment with daily administration of one single sachet on the left hand and 250mg ointment placebo on the right hand for 5 d in a single-blinded manner.</description>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_label>Tirbanibulin</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  o Informed consent&#xD;
  &#xD;
                 -  Diagnosed with AK on both hands&#xD;
  &#xD;
                 -  4-8 AK lesions on each hand, difference in number of lesions &lt; 20%&#xD;
  &#xD;
                 -  Grade of lesions comparable in both hands: non hypertrophic, non-hyperkeratotic&#xD;
  &#xD;
                 -  Willing and able to comply with all study procedures&#xD;
  &#xD;
                 -  Use of medically acceptable contraception (both sexes)&#xD;
  &#xD;
                 -  18 - 99 years of age.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  o History of sensitivity and/or allergy to any of the ingredients in the study&#xD;
               medication.&#xD;
  &#xD;
                 -  Open lesions of any kind on the hands&#xD;
  &#xD;
                 -  Concomitant cutaneous malignancy in treatment area&#xD;
  &#xD;
                 -  Immune deficiency&#xD;
  &#xD;
                 -  Participation in another clinical trial during the last 6 months&#xD;
  &#xD;
                 -  Had been previously treated with Tirbanibulin&#xD;
  &#xD;
                 -  Anticipated need for in-patient hospitalisation or in-patient surgery from Day 1&#xD;
                    to Day 57.&#xD;
  &#xD;
                 -  Treatment with 5-fluorouracil (5-FU), imiquimod, diclofenac, photodynamic&#xD;
                    therapy, or other treatments for AK within the treatment area or within 2 cm of&#xD;
                    the treatment area within 8 weeks prior to the Screening Visit.&#xD;
  &#xD;
                 -  Use of the following therapies and/or medications within 2 weeks prior to the&#xD;
                    Screening Visit:&#xD;
  &#xD;
                      -  Cosmetic or therapeutic procedures (eg, use of liquid nitro-gen, surgical&#xD;
                         excision, curettage, dermabrasion, medium or greater depth chemical peel,&#xD;
                         laser resurfacing) within the treatment area or within 2 cm of the selected&#xD;
                         treat-ment area&#xD;
  &#xD;
                      -  Acid-containing therapeutic products (eg, salicylic acid or fruit acids,&#xD;
                         such as alpha and beta-hydroxyl acids and gly-colic acids), topical&#xD;
                         retinoids, or light chemical peels within the treatment area or within 2 cm&#xD;
                         of the selected treat-ment area&#xD;
  &#xD;
                      -  Topical salves (nonmedicated/nonirritant lotion and cream were acceptable)&#xD;
                         or topical steroids within the treatment area or within 2 cm of the selected&#xD;
                         treatment area; artifi-cial tanners within the treatment area or within 5 cm&#xD;
                         of the selected treatment area.&#xD;
  &#xD;
                 -  Use of the following therapies and/or medications within 4 weeks prior to the&#xD;
                    Screening Visit:&#xD;
  &#xD;
                      -  Treatment with immunomodulators (eg, azathioprine), cy-totoxic drugs (e.g.,&#xD;
                         cyclophosphamide, vinblastine, chlo-rambucil, methotrexate) or&#xD;
                         interferons/interferon induc-ers.&#xD;
  &#xD;
                      -  Treatment with systemic medications that suppress the im-mune system (e.g.,&#xD;
                         cyclosporine, prednisone, methotrex-ate, alefacept, infliximab).&#xD;
  &#xD;
                 -  Use of systemic retinoids (e.g., isotretinoin, acitretin, bexaro-tene) within 6&#xD;
                    months prior to the Screening Visit.&#xD;
  &#xD;
                 -  Skin disease (e.g., atopic dermatitis, psoriasis, eczema) or con-dition (e.g.,&#xD;
                    scarring, open wounds) that, in the opinion of the investigator, might interfere&#xD;
                    with the study conduct or evalu-ations, or which exposed the subject to&#xD;
                    unacceptable risk by study participation.&#xD;
  &#xD;
                 -  Other significant uncontrolled or unstable medical diseases or conditions that,&#xD;
                    in the opinion of the Investigator, would have exposed the subject to&#xD;
                    unacceptable risk by study participa-tion.&#xD;
  &#xD;
                 -  Pregnancy or lactation&#xD;
  &#xD;
                 -  Excessive exposure to UV radiation during study period.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>99 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Wolfgang Weger</last_name>
      <phone>+43385</phone>
      <phone_ext>2371</phone_ext>
      <email>wolfgang.weger@medunigraz.at</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Keratosis, Actinic</mesh_term>
      <mesh_term>Keratosis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tirbanibulin</mesh_term>
    </intervention_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/NCT06026358
  org study id: Tirbanibulin: Back of Hands
  nct id: NCT06026358
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Interventional, monocentric, national, internal placebo-controlled, prospective pilot study,
        consisting of two parts, A (single-blinded) and B (open) to assess Efficacy of Tirbanibulin
        for the treatment of AK on the back of the hand. In part A, eligible subjects receive
        Tirbanibulin on the left hand and placebo on the right hand for 5 d in a single-blinded
        manner. Safety and efficacy are assessed at day 8 (± 1 d) (3 days after the end of treatment
        (EoT+3) and day 57 (± 7 d) after the start of the treatment. Pictures will be taken at
        baseline, 8 d and 57 d (± 7 d) as per protocol and optional during unscheduled visits.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Partial clearance at day 57 ± 7 after start of blinded treatment
  time frame: day 57 ± 7 after start of blinded treatment
  arm group label: Tirbanibulin
  arm group type: Experimental
  description: Treatment
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Placebo
  intervention type: Drug
  intervention name: Tirbanibulin
  description: subjects receive 2,5 mgTirbanibulin in 250 mg ointment with daily administration of one single sachet on the left hand and 250mg ointment placebo on the right hand for 5 d in a single-blinded manner.
  arm group label: Placebo
  arm group label: Tirbanibulin
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 99 Years
  healthy volunteers: No
  last name: Wolfgang Weger
  phone: +43385
  phone ext: 2371
  email: wolfgang.weger@medunigraz.at
  responsible party type: Sponsor
  mesh term: Keratosis, Actinic
  mesh term: Keratosis
  mesh term: Tirbanibulin
  sharing ipd: No