<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/NCT03289013</url>
  </required_header>
  <id_info>
    <org_study_id>CP267_02</org_study_id>
    <nct_id>NCT03289013</nct_id>
  </id_info>
  <brief_title>Assessement of the Peal Force Needed to Peel New Adhesives From the Skin</brief_title>
  <official_title>A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Handle Moisture From Abdominal and Peristomal Skin</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>
      This study investigates the adhesion of new adhesives to the skin.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 11, 2017</start_date>
  <completion_date type="Actual">December 21, 2017</completion_date>
  <primary_completion_date type="Actual">December 21, 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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Swelling of the adhesive</measure>
    <time_frame>21 days</time_frame>
    <description>1. Swelling of adhesive strips measured by weight (Difference between weight of strip before and after test)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Ileostomy - Stoma</condition>
  <arm_group>
    <arm_group_label>Testing of new adhesive strips</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each subject will test six adhesive strips on pre-stripped skin.&#xD;
Standard adhesive 1&#xD;
Standard adhesive 2&#xD;
LT-2&#xD;
LT-21&#xD;
LT-25&#xD;
33-20&#xD;
The six strips are applied on the abdominal skin. The order of the adhesive strips on the skin is randomized. The subjects will change the adhesive strips at home and the adhesion of adhesive strips will be measured at 5 visits.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard adhesive 1</intervention_name>
    <description>This strip consists of a standard hydrocolloid adhesive found in ostomy devices</description>
    <arm_group_label>Testing of new adhesive strips</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard adhesive 2</intervention_name>
    <description>This strip consists of a standard hydrocolloid adhesive found in ostomy devices</description>
    <arm_group_label>Testing of new adhesive strips</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>LT-2</intervention_name>
    <description>Newly developed adhesive</description>
    <arm_group_label>Testing of new adhesive strips</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>LT-21</intervention_name>
    <description>Newly developed adhesive</description>
    <arm_group_label>Testing of new adhesive strips</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>LT-25</intervention_name>
    <description>Newly developed adhesive</description>
    <arm_group_label>Testing of new adhesive strips</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>33-20</intervention_name>
    <description>Newly developed adhesive</description>
    <arm_group_label>Testing of 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 intact skin on the area used in the investigation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Currently receiving or have within the past 2 months received radio- and/or&#xD;
             chemotherapy&#xD;
&#xD;
          2. Currently receiving or have within the past months received topical steroid treatment&#xD;
             in the abdominal skin area or systemic steroid (tablet/injection) treatment.&#xD;
&#xD;
          3. Are pregnant or breastfeeding&#xD;
&#xD;
          4. Have dermatological problems in the abdominal area (assessed by investigator)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lene Feldskov</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>January 2018</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>January 31, 2018</last_update_submitted>
  <last_update_submitted_qc>January 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2018</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/NCT03289013
org study id: CP267_02
nct id: NCT03289013
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study investigates the adhesion of new adhesives to the skin.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Swelling of the adhesive
time frame: 21 days
description: 1. Swelling of adhesive strips measured by weight (Difference between weight of strip before and after test)
arm group label: Testing of new adhesive strips
arm group type: Experimental
description: Each subject will test six adhesive strips on pre-stripped skin.
Standard adhesive 1
Standard adhesive 2
LT-2
LT-21
LT-25
33-20
The six strips are applied on the abdominal skin. The order of the adhesive strips on the skin is randomized. The subjects will change the adhesive strips at home and the adhesion of adhesive strips will be measured at 5 visits.
intervention type: Other
intervention name: Standard adhesive 1
description: This strip consists of a standard hydrocolloid adhesive found in ostomy devices
arm group label: Testing of new adhesive strips
intervention type: Other
intervention name: Standard adhesive 2
description: This strip consists of a standard hydrocolloid adhesive found in ostomy devices
arm group label: Testing of new adhesive strips
intervention type: Other
intervention name: LT-2
description: Newly developed adhesive
arm group label: Testing of new adhesive strips
intervention type: Other
intervention name: LT-21
description: Newly developed adhesive
arm group label: Testing of new adhesive strips
intervention type: Other
intervention name: LT-25
description: Newly developed adhesive
arm group label: Testing of new adhesive strips
intervention type: Other
intervention name: 33-20
description: Newly developed adhesive
arm group label: Testing of new adhesive strips
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Lene Feldskov
role: Principal Investigator
affiliation: Head of preclinical department
facility: 
country: Denmark
responsible party type: Sponsor