<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/NCT02241057</url>
  </required_header>
  <id_info>
    <org_study_id>2014011</org_study_id>
    <nct_id>NCT02241057</nct_id>
  </id_info>
  <brief_title>Investigational Air-Activated Adhesive-Backed Heat Patch (3-Cell)</brief_title>
  <official_title>A Randomized, Open-Label Study to Evaluate the Temperature Profile and Adhesion of an Air-Activated Adhesive-Backed Heat Patch in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chattem, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chattem, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open-label study. A total of approximately 60 subjects will be randomly assigned&#xD;
      to receive either the heat patch (30 subjects) with a temperature probe/skin reference probe&#xD;
      or a heat patch (30 subjects) alone. The study will consist of 2 visits.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">September 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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patch Temperature</measure>
    <time_frame>8 hours</time_frame>
    <description>The temperature of the patch will be monitored by the use of a probe placed under the patch and recorded for the duration of the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patch Adhesion</measure>
    <time_frame>8 hours</time_frame>
    <description>Patch adhesion will be recorded for the duration of the study.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Temperature</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Evaluate the temperature profile of the air activated 3-cell patch during 8 hours of wear</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adhesion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Evaluate the adhesion with and without the presence of a temperature probe</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Investigational Air-Activated Adhesive-Backed Heat Patch (3-Cell)</intervention_name>
    <arm_group_label>Adhesion</arm_group_label>
    <arm_group_label>Temperature</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Temperature Probe</intervention_name>
    <arm_group_label>Temperature</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects who complete an appropriately administered informed consent process that&#xD;
             includes signing the consent form.&#xD;
&#xD;
          -  Subjects 18-75 years old of either sex.&#xD;
&#xD;
          -  Are of any skin type or race, providing the skin pigmentation will allow discernment&#xD;
             of erythema;&#xD;
&#xD;
          -  Subjects who are in good general health.&#xD;
&#xD;
          -  Subjects who are willing and able to have the test products applied as directed, and&#xD;
             comply with study instructions.&#xD;
&#xD;
          -  Participants must be willing to restrict their activity for the 8 hour patch wear&#xD;
             time.&#xD;
&#xD;
          -  All participants agree to wear a t-shirt provided by the site for the entire 8 hour&#xD;
             patch wear time.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who have a history of sensitivity to any of the test products or adhesion&#xD;
             material.&#xD;
&#xD;
          -  Subjects who are pregnant.&#xD;
&#xD;
          -  Subject with excessive hair at the application sites, scar tissue, tattoo, or&#xD;
             coloration that would interfere with placement of test product or skin assessment.&#xD;
&#xD;
          -  Subjects with diabetes, rheumatoid arthritis, poor circulation or have any clinically&#xD;
             significant chronic illness.&#xD;
&#xD;
          -  Subjects with active dermatitis (including sunburn) in the treatment area, or other&#xD;
             visible dermatological disease which, in the investigator's opinion, might interfere&#xD;
             with the response to the test products or interfere with the skin assessments&#xD;
             associated with the test products.&#xD;
&#xD;
          -  Have history of significant dermatologic cancers (eg, melanoma, squamous cell&#xD;
             carcinoma).&#xD;
&#xD;
          -  Subjects who have used topical dermatological products in the application area within&#xD;
             24 hours prior to the test product application.&#xD;
&#xD;
          -  Subject using a concomitant medication that, in the investigator's opinion, could&#xD;
             interfere with the interpretation of study results. Examples of such drugs include&#xD;
             non-steroidal anti-inflammatory drugs (NSAIDs, e.g., aspirin), topical or systemic&#xD;
             corticosteroids, and cold/cough products containing antihistamines and/or either&#xD;
             phentolamine, pseudoephedrine or phenylpropanolamine.&#xD;
&#xD;
          -  Subjects who have received an investigational medication or device within 30 days&#xD;
             prior to enrolment into this study.&#xD;
&#xD;
          -  Subjects who are currently participating in an investigational study.&#xD;
&#xD;
          -  Subject who are known to be noncompliant or are unlikely to comply with the&#xD;
             requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental&#xD;
             incapacity) in the opinion of the investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ellen Bonagua, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chattem, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wilkins Research</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37421</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>March 15, 2017</last_update_submitted>
  <last_update_submitted_qc>March 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>temperature profile</keyword>
  <keyword>air activated 3-cell patch</keyword>
  <keyword>adhesion</keyword>
  <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/NCT02241057
org study id: 2014011
nct id: NCT02241057
lead sponsor: 
has dmc: Yes
This is an open-label study. A total of approximately 60 subjects will be randomly assigned
      to receive either the heat patch (30 subjects) with a temperature probe/skin reference probe
      or a heat patch (30 subjects) alone. The study will consist of 2 visits.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Patch Temperature
time frame: 8 hours
description: The temperature of the patch will be monitored by the use of a probe placed under the patch and recorded for the duration of the study.
measure: Patch Adhesion
time frame: 8 hours
description: Patch adhesion will be recorded for the duration of the study.
arm group label: Temperature
arm group type: Experimental
description: Evaluate the temperature profile of the air activated 3-cell patch during 8 hours of wear
arm group label: Adhesion
arm group type: Experimental
description: Evaluate the adhesion with and without the presence of a temperature probe
intervention type: Device
intervention name: Investigational Air-Activated Adhesive-Backed Heat Patch (3-Cell)
arm group label: Adhesion
arm group label: Temperature
intervention type: Other
intervention name: Temperature Probe
arm group label: Temperature
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ellen Bonagua, MD
role: Principal Investigator
affiliation: Chattem, Inc.
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No