<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/NCT01703078</url>
  </required_header>
  <id_info>
    <org_study_id>LP0084-68</org_study_id>
    <nct_id>NCT01703078</nct_id>
  </id_info>
  <brief_title>Safety and Tolerability of Different Concentrations of an Ingenol Derivative Field Therapy in the Treatment of Actinic Keratosis</brief_title>
  <official_title>A Phase 1 Exploratory Trial Evaluating Safety and Tolerability of Topical Administration of Different Concentrations of an Ingenol Derivative Compared to Ingenol Mebutate Gel 0.05% Applied on Two Consecutive Days to Four Separate 25cm2 Treatment Areas on the Forearms of Subjects With Actinic Keratosis (Field Therapy)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LEO Pharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>LEO Pharma</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if the new ingenol derivative gels are as safe as&#xD;
      and as well tolerated as ingenol mebutate gel when applied to AK lesions on the forearm for&#xD;
      two consecutive days.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Various concentrations of new ingenol derivatives will be applied to AKs on the forearms.&#xD;
      Reactions and safety will be compared to a US registered and marketed ingenol gel to&#xD;
      ascertain if the new ingenol is at least as safe and as well tolerated as the registered&#xD;
      ingenol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety of a new ingenol derivative compared to ingenol mebutate gel applied topically once daily for two consecutive days to four separate treatment areas containing actinic keratosis on the forearm</measure>
    <time_frame>8 weeks</time_frame>
    <description>Safety data to be collected via CRF entries of AEs/SAEs and photographs.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate treatment responses on Actinic Keratosis of different concentrations of a new ingenol derivative gel compared to the ingenol mebutate gel as assessed by reduction in number of clinically visible selected AK lesions eight weeks after treatment</measure>
    <time_frame>8 weeks</time_frame>
    <description>Assessed by Reflective Confocal Microscopy scoring of visible selected AK lesions</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Actinic Keratosis</condition>
  <arm_group>
    <arm_group_label>Ingenol mebutate gel 0.05%</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>once daily for two consecutive days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ingenol derivative concentration 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>once daily for two consecutive days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ingenol derivative concentration 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>once daily for two consecutive days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ingenol derivative concentration 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>once daily for two consecutive days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ingenol once daily for two consecutive days</intervention_name>
    <arm_group_label>Ingenol derivative concentration 1</arm_group_label>
    <arm_group_label>Ingenol derivative concentration 2</arm_group_label>
    <arm_group_label>Ingenol derivative concentration 3</arm_group_label>
    <arm_group_label>Ingenol mebutate gel 0.05%</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must be male or female and at least 18 years of age.&#xD;
&#xD;
          -  Female patients must be of non-childbearing potential or if of childbearing potential&#xD;
             then negative serum and urine pregnancy test and using effective contraception&#xD;
&#xD;
          -  Ability to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  location of the selected treatment area within 5cm of an incompletely healed wound or&#xD;
             within 5cm of a suspected basal cell carcinoma or squamous cell carcinoma&#xD;
&#xD;
          -  undergone Cosmetic or therapeutic procedures within 2cm of the selected treatment area&#xD;
             in the 2 weeks prior to Visit 2&#xD;
&#xD;
          -  use of acid-containing therapeutic products within 2cm of the selected treatment area&#xD;
             in the 2 weeks prior to Visit 2&#xD;
&#xD;
          -  use of topical moisturisers/creams/lotions, artificial tanners or topical steroids&#xD;
             within 2cm of the selected treatment areas in the 2 weeks prior to visit 2 Treatment&#xD;
             with immunomodulators, or interferon/interferon inducers or systemic medications that&#xD;
             suppress the immune system within 4 weeks of Visit 2&#xD;
&#xD;
          -  Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy within 2 cm of the&#xD;
             treatment area in the 8 weeks prior to visit 2&#xD;
&#xD;
          -  use of systemic retinoids&#xD;
&#xD;
          -  those who are currently participating in any other clinical trial&#xD;
&#xD;
          -  females who are pregnant or are breastfeeding&#xD;
&#xD;
          -  those known or suspected of not being able to comply with the requirements of the&#xD;
             protocol or provide consent&#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>Hans P Soyer</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dermatology Department, Brisbane Public Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dermatology Department</name>
      <address>
        <city>Woolloongabba</city>
        <state>Queensland</state>
        <zip>4102</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <link>
    <url>http://www.leopharma.com</url>
    <description>LEO Pharma</description>
  </link>
  <link>
    <url>http://www.tga.gov.au</url>
    <description>Therapeutic Goods Administration</description>
  </link>
  <verification_date>February 2013</verification_date>
  <study_first_submitted>October 5, 2012</study_first_submitted>
  <study_first_submitted_qc>October 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <last_update_submitted>April 3, 2013</last_update_submitted>
  <last_update_submitted_qc>April 3, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 4, 2013</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>
  <!-- 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/NCT01703078
org study id: LP0084-68
nct id: NCT01703078
lead sponsor: 
has dmc: No
The purpose of this study is to determine if the new ingenol derivative gels are as safe as
      and as well tolerated as ingenol mebutate gel when applied to AK lesions on the forearm for
      two consecutive days.
Various concentrations of new ingenol derivatives will be applied to AKs on the forearms.
      Reactions and safety will be compared to a US registered and marketed ingenol gel to
      ascertain if the new ingenol is at least as safe and as well tolerated as the registered
      ingenol.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Safety of a new ingenol derivative compared to ingenol mebutate gel applied topically once daily for two consecutive days to four separate treatment areas containing actinic keratosis on the forearm
time frame: 8 weeks
description: Safety data to be collected via CRF entries of AEs/SAEs and photographs.
measure: Evaluate treatment responses on Actinic Keratosis of different concentrations of a new ingenol derivative gel compared to the ingenol mebutate gel as assessed by reduction in number of clinically visible selected AK lesions eight weeks after treatment
time frame: 8 weeks
description: Assessed by Reflective Confocal Microscopy scoring of visible selected AK lesions
arm group label: Ingenol mebutate gel 0.05%
arm group type: Active Comparator
description: once daily for two consecutive days
arm group label: Ingenol derivative concentration 1
arm group type: Experimental
description: once daily for two consecutive days
arm group label: Ingenol derivative concentration 2
arm group type: Experimental
description: once daily for two consecutive days
arm group label: Ingenol derivative concentration 3
arm group type: Experimental
description: once daily for two consecutive days
intervention type: Drug
intervention name: Ingenol once daily for two consecutive days
arm group label: Ingenol derivative concentration 1
arm group label: Ingenol derivative concentration 2
arm group label: Ingenol derivative concentration 3
arm group label: Ingenol mebutate gel 0.05%
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hans P Soyer
role: Principal Investigator
affiliation: Dermatology Department, Brisbane Public Hospital
facility: 
country: Australia
url: http://www.leopharma.com
description: LEO Pharma
url: http://www.tga.gov.au
description: Therapeutic Goods Administration
responsible party type: Sponsor
mesh term: Keratosis, Actinic
mesh term: Keratosis