<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/NCT03257774</url>
  </required_header>
  <id_info>
    <org_study_id>CP265_12_13_14</org_study_id>
    <nct_id>NCT03257774</nct_id>
  </id_info>
  <brief_title>Evaluation of the Effect of Output on New Adhesives</brief_title>
  <official_title>A Pilot Evaluation of Newly Developed Adhesives and How They Are Impacted by Output</official_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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study investigates the impanct real output has on the adhesion of a new adhesive&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 19, 2017</start_date>
  <completion_date type="Actual">September 13, 2017</completion_date>
  <primary_completion_date type="Actual">September 13, 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>
    <description>The trans epidermal water loss is measured on the peristomal skin using a probe. Thrans epidermal water loss is a measure for the skins barrier function. There is always a loss of water from the skin du to natural evaporation. However, when the skin barrier is damaged more water can evaporate. Trans epridermal water loss is used to assess the damage to the skin.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Ileostomy - Stoma</condition>
  <arm_group>
    <arm_group_label>Test of three new adhesive strips</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subjects test three new adhesive strips&#xD;
adhesive strip A&#xD;
adhesive strip B&#xD;
adhesive strip C</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Adhesive strip A</intervention_name>
    <description>Strip consisting of a newly developed adhesive</description>
    <arm_group_label>Test of three new adhesive strips</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Adhesive strip B</intervention_name>
    <description>Strip consisting of a newly developed adhesive</description>
    <arm_group_label>Test of three new adhesive strips</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Adhesive strip C</intervention_name>
    <description>Strip consisting of a newly developed adhesive</description>
    <arm_group_label>Test of three new adhesive strips</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Have given written informed consent&#xD;
&#xD;
          2. Be at least 18 years of age and have full legal capacity&#xD;
&#xD;
          3. Have had a stoma for more than one year&#xD;
&#xD;
          4. Have intact skin on the area used in the evalua-tion&#xD;
&#xD;
          5. Has a stoma with a diameter up to (≤) 35 mm&#xD;
&#xD;
          6. Have a peristomal area accessible for application of adhesive strips (assessed by&#xD;
             investigating scientist)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Currently receiving or have within the past 2 month received radio- and/or&#xD;
             chemotherapy&#xD;
&#xD;
          2. 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;
          3. Are pregnant or breastfeeding&#xD;
&#xD;
          4. Having dermatological problems in the peristo-mal- or abdominal area (assessed by&#xD;
             investigating scientist)&#xD;
&#xD;
          5. Actively participating in other interventional clinical investigations or have&#xD;
             previously participated in this investigation&#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</last_name>
    <role>Principal Investigator</role>
    <affiliation>Head of preclinical department</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Coloplast A/S</name>
      <address>
        <city>Humlebæk</city>
        <zip>3050</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>November 7, 2017</last_update_submitted>
  <last_update_submitted_qc>November 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03257774
org study id: CP265_12_13_14
nct id: NCT03257774
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study investigates the impanct real output has on the adhesion of a new adhesive
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
description: The trans epidermal water loss is measured on the peristomal skin using a probe. Thrans epidermal water loss is a measure for the skins barrier function. There is always a loss of water from the skin du to natural evaporation. However, when the skin barrier is damaged more water can evaporate. Trans epridermal water loss is used to assess the damage to the skin.
arm group label: Test of three new adhesive strips
arm group type: Experimental
description: The subjects test three new adhesive strips
adhesive strip A
adhesive strip B
adhesive strip C
intervention type: Other
intervention name: Adhesive strip A
description: Strip consisting of a newly developed adhesive
arm group label: Test of three new adhesive strips
intervention type: Other
intervention name: Adhesive strip B
description: Strip consisting of a newly developed adhesive
arm group label: Test of three new adhesive strips
intervention type: Other
intervention name: Adhesive strip C
description: Strip consisting of a newly developed adhesive
arm group label: Test of three new adhesive strips
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lene F Nielsen
role: Principal Investigator
affiliation: Head of preclinical department
facility: 
country: Denmark
responsible party type: Sponsor