<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/NCT01691209</url>
  </required_header>
  <id_info>
    <org_study_id>16200</org_study_id>
    <secondary_id>2012-001504-38</secondary_id>
    <nct_id>NCT01691209</nct_id>
  </id_info>
  <brief_title>Efficacy/Safety Study to Explore a New Topical Formulation in Atopic Dermatitis</brief_title>
  <acronym>Phoenix</acronym>
  <official_title>An Investigator-blinded, Randomized, Monocentre, 3-arm, Active Controlled Pilot Trial to Explore the Efficacy and Safety of a Topical Medical Device in Patients With Mild to Moderate Atopic Dermatitis in an Intra-individual Comparison With a Standard Therapy (1% Hydrocortisone Cream) and Untreated Skin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bayer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study shall explore whether treatment of atopic dermatitis is equally effective with&#xD;
      Phoenix medical device as compared to standard therapy (Hydrocortisone cream).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <start_date>October 2013</start_date>
  <completion_date type="Anticipated">June 2014</completion_date>
  <primary_completion_date type="Anticipated">April 2014</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <secondary_outcome>
    <measure>Number of participants with abnormal vital signs</measure>
    <time_frame>Up to 10 weeks</time_frame>
    <description>Vital signs consist of blood pressure, heart rate and body temperature.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events as a measure of safety and tolerability</measure>
    <time_frame>Up to 10 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Local scored atopic dermatitis (SCORAD) as clinical assessment by means of the intensity items of the SCORAD index</measure>
    <time_frame>Up to 29 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Transepidermal water loss (TEWL) as a measure for skin barrier function</measure>
    <time_frame>Up to 29 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Skin hydration by means of corneometry</measure>
    <time_frame>Up to 29 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Erythema by means of chromametry</measure>
    <time_frame>Up to 29 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Intensity of pruritus by means of visual analogue scale (VAS)</measure>
    <time_frame>Up to 29 days</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Dermatitis, Atopic</condition>
  <arm_group>
    <arm_group_label>Phoenix</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Application over 29 days twice daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hydrocortison</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Application over 29 days twice daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Untreated skin</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will be observed over 29 days without study treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Phoenix (BAY81-2996)</intervention_name>
    <description>Topical formulation applied to the skin</description>
    <arm_group_label>Phoenix</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>1% Hydrocortison cream</intervention_name>
    <description>1% Hydrocortison cream applied to the skin</description>
    <arm_group_label>Hydrocortison</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female Caucasians aged between 18 and 60 years&#xD;
&#xD;
          -  Patients with mild atopic dermatitis (AD) presenting a scoring AD (SCORAD) rating&#xD;
             below 50&#xD;
&#xD;
          -  Skin type I - IV according to Fitzpatrick&#xD;
&#xD;
          -  Acute AD symptoms on each assessment areas (local SCORAD ≥ 3 and &lt;= 12) at Baseline&#xD;
&#xD;
          -  Acute symptom of pruritus at Baseline&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any other skin disease at the test area that would interfere with the clinical&#xD;
             assessment in the opinion of the investigator&#xD;
&#xD;
          -  Moles, tattoos, strong pigmentation, or scars at the test area that would interfere&#xD;
             with the clinical assessment&#xD;
&#xD;
          -  Regular intake of antiphlogistic drugs (for example nonsteroidal anti-inflammatory&#xD;
             drugs [NSAIDs])&#xD;
&#xD;
          -  Any condition or treatment which might influence the trial (e.g. any treatment with&#xD;
             topical antibiotics, antifungals, or corticoids) within 14 days prior to screening as&#xD;
             well as during the trial (exception: topical treatment of AD lesions other than the&#xD;
             test areas (for example, face) with low potency steroids restricted to small areas)&#xD;
&#xD;
          -  UV-therapy or the use of solarium within 30 days before screening as well as during&#xD;
             the trial&#xD;
&#xD;
          -  Any alternative treatment of AD (e.g. acupuncture, kinesiology, and homoeopathy)&#xD;
             within 30 days before screening as well as during the trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bayer Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Bayer</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Münster</city>
        <state>Nordrhein-Westfalen</state>
        <zip>48155</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2013</verification_date>
  <study_first_submitted>September 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <last_update_submitted>August 9, 2013</last_update_submitted>
  <last_update_submitted_qc>August 9, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 13, 2013</last_update_posted>
  <responsible_party>
    <name_title>Head Medical Affairs</name_title>
    <organization>Bayer HealthCare AG, Consumer Care</organization>
  </responsible_party>
  <keyword>Phoenix</keyword>
  <keyword>Hydrocortison</keyword>
  <keyword>mild atopic dermatitis</keyword>
  <keyword>efficacy</keyword>
  <keyword>safety</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>Hydrocortisone</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/NCT01691209
org study id: 16200
secondary id: 2012-001504-38
nct id: NCT01691209
lead sponsor: 
has dmc: No
The study shall explore whether treatment of atopic dermatitis is equally effective with
      Phoenix medical device as compared to standard therapy (Hydrocortisone cream).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Number of participants with abnormal vital signs
time frame: Up to 10 weeks
description: Vital signs consist of blood pressure, heart rate and body temperature.
measure: Number of participants with adverse events as a measure of safety and tolerability
time frame: Up to 10 weeks
measure: Local scored atopic dermatitis (SCORAD) as clinical assessment by means of the intensity items of the SCORAD index
time frame: Up to 29 days
measure: Transepidermal water loss (TEWL) as a measure for skin barrier function
time frame: Up to 29 days
measure: Skin hydration by means of corneometry
time frame: Up to 29 days
measure: Erythema by means of chromametry
time frame: Up to 29 days
measure: Intensity of pruritus by means of visual analogue scale (VAS)
time frame: Up to 29 days
arm group label: Phoenix
arm group type: Experimental
description: Application over 29 days twice daily
arm group label: Hydrocortison
arm group type: Active Comparator
description: Application over 29 days twice daily
arm group label: Untreated skin
arm group type: No Intervention
description: Participants will be observed over 29 days without study treatment
intervention type: Device
intervention name: Phoenix (BAY81-2996)
description: Topical formulation applied to the skin
arm group label: Phoenix
intervention type: Drug
intervention name: 1% Hydrocortison cream
description: 1% Hydrocortison cream applied to the skin
arm group label: Hydrocortison
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
facility: 
country: Germany
name title: Head Medical Affairs
organization: Bayer HealthCare AG, Consumer Care
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
mesh term: Hydrocortisone