<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/NCT03000881</url>
  </required_header>
  <id_info>
    <org_study_id>CP265_06</org_study_id>
    <nct_id>NCT03000881</nct_id>
  </id_info>
  <brief_title>Evaluation of the Influence of Output on Skin Covered by Adhesives</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Coloplast A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Coloplast A/S</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study investigates the impact real output has on peristomal skin covered by two different&#xD;
      adhesives&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">April 4, 2017</completion_date>
  <primary_completion_date type="Actual">April 4, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Trans Epidermal Water Loss</measure>
    <time_frame>8 hours</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Ileostomy - Stoma</condition>
  <arm_group>
    <arm_group_label>Cohort 6</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is a sub-study testing the effect of real output applied under two adhesive strips after 8 hours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>standard adhesive</intervention_name>
    <description>This is a standard adhesive (hydrocolloid)</description>
    <arm_group_label>Cohort 6</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>New adhesive strip</intervention_name>
    <description>This is a newly developed adhesive strip</description>
    <arm_group_label>Cohort 6</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have given written informed consent&#xD;
&#xD;
          -  Be at least 18 years of age and have full legal capacity&#xD;
&#xD;
          -  Have had an ileostomy for more than one year&#xD;
&#xD;
          -  Have intact skin on the area used in the evaluation&#xD;
&#xD;
          -  Has an ileostomy with a diameter up to 35 mm&#xD;
&#xD;
          -  Have a peristomal area accessible for application of adhesive strips&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently receiving or have within the past 2 month received radio- and/or&#xD;
             chemotherapy&#xD;
&#xD;
          -  Currently receiving or have within the past month received topical steroid treatment&#xD;
             in the peristomal skin area or systemic steroid (tablet/injection) treatment.&#xD;
&#xD;
          -  Are pregnant or breastfeeding&#xD;
&#xD;
          -  Having dermatological problems in the peristomal- or abdominal area (assessed by&#xD;
             investigating scientist)&#xD;
&#xD;
          -  Participating in other interventional clinical investigations or have previously&#xD;
             participated in this evaluation -&#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>Lene F Nielsen, M. Sc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Head of preclinical department</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Coloplast A/S</name>
      <address>
        <city>Humlebaek</city>
        <zip>3050</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>May 29, 2017</last_update_submitted>
  <last_update_submitted_qc>May 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT03000881
org study id: CP265_06
nct id: NCT03000881
lead sponsor: 
has dmc: No
The study investigates the impact real output has on peristomal skin covered by two different
      adhesives
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Trans Epidermal Water Loss
time frame: 8 hours
arm group label: Cohort 6
arm group type: Experimental
description: This is a sub-study testing the effect of real output applied under two adhesive strips after 8 hours.
intervention type: Other
intervention name: standard adhesive
description: This is a standard adhesive (hydrocolloid)
arm group label: Cohort 6
intervention type: Other
intervention name: New adhesive strip
description: This is a newly developed adhesive strip
arm group label: Cohort 6
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lene F Nielsen, M. Sc
role: Principal Investigator
affiliation: Head of preclinical department
facility: 
country: Denmark
responsible party type: Sponsor
sharing ipd: No