<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/NCT02219633</url>
  </required_header>
  <id_info>
    <org_study_id>LP0083-1085</org_study_id>
    <secondary_id>2014-000849-80</secondary_id>
    <nct_id>NCT02219633</nct_id>
  </id_info>
  <brief_title>Effect of LEO 39652 Cream in Adults With Mild to Moderate Atopic Dermatitis (AD)</brief_title>
  <official_title>An Explorative Trial Evaluating the Effect of LEO 39652 Cream in Adults With Mild to Moderate Atopic Dermatitis (AD)</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 aim of this trial is to assess the efficacy of LEO 39652 cream compared with LEO 39652&#xD;
      cream vehicle in adults with mild to moderate AD after 3 weeks of treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total sign score at end of treatment</measure>
    <time_frame>22 days</time_frame>
    <description>Total Sign Score is defined as the sum of severity scores (4-point scale) of the Individual Sign Scores(erythema, edema/papulation, oozing/crusting, excoriations, lichenification and dryness)for each assessed area.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total sign score on limited treatment area</measure>
    <time_frame>22 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigator's treatment area assessment of disease severity</measure>
    <time_frame>22 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject´s treatment area assessment of disease severity</measure>
    <time_frame>22 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject´s assessment of itching</measure>
    <time_frame>22 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transepidermal Water Loss</measure>
    <time_frame>22 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>LEO 39652 cream</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Topical application</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LEO 39652 cream vehicle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Topical application</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LEO 39652 cream</intervention_name>
    <description>Applied for 21 days</description>
    <arm_group_label>LEO 39652 cream</arm_group_label>
    <arm_group_label>LEO 39652 cream vehicle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with Atopic Dermatitis (AD) as defined by Hanifin and Rajka criteria and with&#xD;
             mild to moderate disease severity (IGA 2 or 3)&#xD;
&#xD;
          -  Two symmetrical and comparable Entire Treatment Areas, on the same body region (left&#xD;
             and right part)&#xD;
&#xD;
          -  Subjects must be in good health&#xD;
&#xD;
          -  Female subjects of childbearing potential and male subjects must be willing to consent&#xD;
             to using high effective methods of contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any condition in the treatment areas that in the opinion of the investigator could&#xD;
             interfere with clinical assessments, e.g. acne, infection, rash (other than atopic&#xD;
             dermatitis), sunburn, hyper-or hypopigmentation, scars&#xD;
&#xD;
          -  Dark-skinned persons (i.e. skin type IV to VI according to Fitzpatrick classification&#xD;
             system) whose skin colour prevents reliable clinical assessments&#xD;
&#xD;
          -  Any permanent (or transient within 28 days prior to dosing) disease (in particular&#xD;
             cardiac disease such as heart failure or history of myocardial infarction) that may&#xD;
             interfere with the subjects safe participation in the trial, with the subjects ability&#xD;
             to participate in the trial or with the clinical assessments&#xD;
&#xD;
          -  Subjects with congenital or acquired immunodeficiencies or in subjects on therapy that&#xD;
             causes immunosuppression&#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>Lydia Graßhoff, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Proinnovera GmbH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>proinnovera GmbH, Center of Dermatology Excellence</name>
      <address>
        <city>Münster</city>
        <zip>48159</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>June 13, 2016</last_update_submitted>
  <last_update_submitted_qc>June 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 14, 2016</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>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/NCT02219633
org study id: LP0083-1085
secondary id: 2014-000849-80
nct id: NCT02219633
lead sponsor: 
has dmc: No
The aim of this trial is to assess the efficacy of LEO 39652 cream compared with LEO 39652
      cream vehicle in adults with mild to moderate AD after 3 weeks of treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Total sign score at end of treatment
time frame: 22 days
description: Total Sign Score is defined as the sum of severity scores (4-point scale) of the Individual Sign Scores(erythema, edema/papulation, oozing/crusting, excoriations, lichenification and dryness)for each assessed area.
measure: Total sign score on limited treatment area
time frame: 22 days
measure: Investigator's treatment area assessment of disease severity
time frame: 22 days
measure: Subject´s treatment area assessment of disease severity
time frame: 22 days
measure: Subject´s assessment of itching
time frame: 22 days
measure: Transepidermal Water Loss
time frame: 22 days
arm group label: LEO 39652 cream
arm group type: Experimental
description: Topical application
arm group label: LEO 39652 cream vehicle
arm group type: Placebo Comparator
description: Topical application
intervention type: Drug
intervention name: LEO 39652 cream
description: Applied for 21 days
arm group label: LEO 39652 cream
arm group label: LEO 39652 cream vehicle
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lydia Graßhoff, MD
role: Principal Investigator
affiliation: Proinnovera GmbH
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema