<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/NCT02221726</url>
  </required_header>
  <id_info>
    <org_study_id>CR105188</org_study_id>
    <secondary_id>FENPAI1024</secondary_id>
    <nct_id>NCT02221726</nct_id>
  </id_info>
  <brief_title>Study to Assess Adhesion Quality and Wear of Placebo JNJ-35685-AAA-G-023 Transdermal System in Healthy Adults</brief_title>
  <official_title>Evaluation of Scoring Methods to Assess Adhesion Quality and Wear of the Placebo JNJ-35685-AAA-G-023 5.5 cm^2 and 44 cm^2 Transdermal Systems</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Research &amp; Development, LLC</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess 3 different scoring systems to evaluate the adhesive&#xD;
      quality of placebo (an inactive substance that is compared with a drug to test whether the&#xD;
      drug has a real effect in a clinical trial]) JNJ-35685-AAA-G-023-G transdermal (through the&#xD;
      skin) systems during a single system 72-hour application, replicated 3 times, of 2 patch&#xD;
      sizes (5.5 centimeter^2 [cm^2] and 44 cm^2).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will assess 3 different scoring systems to evaluate the adhesive quality of&#xD;
      &quot;placebo&quot; patch (an inactive patch that contains no active drug), JNJ-35685-AAA-G-023-G&#xD;
      transdermal (through the skin) system. In this study, this patch is NOT being compared to a&#xD;
      patch with a drug, and is NOT being used to test if the patch with the drug has a real effect&#xD;
      in a clinical trial. The study consists 3 parts: Screening (21 days before study commences on&#xD;
      Day 1), an adhesion assessment period (4 days), and an end of Study (EOS) assessment&#xD;
      (recorded at 24 hours +/- 4 hours following patch removal). Total study duration per&#xD;
      participant will be 26 days (including Screening). JNJ-35685-AAA-G-023 small (5.5 cm^2) and&#xD;
      large (44 cm^2) patches will be applied on to left or right side of the paraspinal region&#xD;
      based on randomization schedule. Adhesion assessments will be performed at patch application&#xD;
      (hour 0, Baseline), and during the time interval of 8 to 10 hours, 24, 48, and 72 hours&#xD;
      following patch application. Adhesion quality will be assessed by visual grading, United&#xD;
      States Food and Drug Administration (FDA) scale, digital image analysis and visual grading&#xD;
      grid system. Participants' safety will be monitored throughout the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <phase>Early Phase 1</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Grading United States Food and Drug Administration (FDA) Scale Score</measure>
    <time_frame>Baseline up to 72 hours following patch application</time_frame>
    <description>Visual grading US FDA scale will be used to evaluate adhesion performance of the transdermal system. The score ranges from 0-4: 0 = greater than or equal to (&gt;=) 90 percent (%) adhered (essentially no lift off the skin); 1 = greater than or equal to 75% to less than (&lt;) 90% adhered (some edges only lifting off the skin); 2 = greater than or equal to 50% to &lt;75% adhered (less than half of the patch lifting off the skin); 3 = greater than (&gt;) 0% to &lt;50% adhered but not detached (more than half of the patch lifting off the skin without falling off); and 4 = 0% adhered - patch detached (patch completely off the skin).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adhesion Area Calculated by Digital Image Analysis</measure>
    <time_frame>Baseline up to 72 hours following patch application</time_frame>
    <description>Digital image will be captured with high resolution for each transdermal patch site and adhesion area will be calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Adhesion Score Calculated by Visual Grading Grid System</measure>
    <time_frame>Baseline up to 72 hours following patch application</time_frame>
    <description>Total adhesion score will be calculated by visual grading grid system (a grid system based on 20 four-sided divisions that are approximately 5% of the total patch area; 44 cm^2 patch will be evaluated by square and rectangular grid elements while 5.5 cm^2 patch will be evaluated by square grid element only) which also contains a scale to allow for proper determination of actual area of the patch not adhering to the skin. Total area of the patch which does not adhere will be calculated. Any area of the patch that does not entirely adhere onto the skin will be scored as 0% adhesion for that area. Subsequently, a total adhesion score for that system will be calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events (AEs) and Serious AEs</measure>
    <time_frame>Baseline up to 72 hours following patch application</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>JNJ-35684-AAA-023: 5.5 cm^2 Patch</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>JNJ-35684-AAA-023: 44 cm^2 Patch</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-35684-AAA-023: Size 1; small patch</intervention_name>
    <description>Placebo (matched to Fentanyl transdermal delivery device system [TDDS]) JNJ-35685-AAA-G-023 TDDS, 5.5 centimeter square (cm^2) will be applied vertically to 1 side of the paraspinal region, replicated 3 times, and worn for 72 hours.</description>
    <arm_group_label>JNJ-35684-AAA-023: 5.5 cm^2 Patch</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-35684-AAA-023: Size 2; large patch</intervention_name>
    <description>Placebo (matched to Fentanyl transdermal delivery device system [TDDS]) JNJ-35685-AAA-G-023 TDDS, 44 cm^2 (Size 1; small patch) will be applied vertically to other side of the paraspinal region, replicated 3 times, and worn for 72 hours.</description>
    <arm_group_label>JNJ-35684-AAA-023: 44 cm^2 Patch</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body mass index (BMI: weight in kilogram [kg]/height^2 [meter (m^2)]) between 18 and&#xD;
             35 kg/m^2 (inclusive), and body weight not less than 50 kg&#xD;
&#xD;
          -  Blood pressure (can be taken in supine or sitting position) between 90 and 140&#xD;
             milimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic&#xD;
&#xD;
          -  Non-smoker (for at least 6 months prior to screening) and willing to abstain from&#xD;
             smoking during the study confinement period&#xD;
&#xD;
          -  Good general health as determined by medical history, physical examination,&#xD;
             electrocardiogram (ECG) and clinical laboratory tests&#xD;
&#xD;
          -  Willing to adhere to the prohibitions and restrictions specified in this protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of or current clinically significant medical illness including but not limited&#xD;
             to, cardiac arrhythmias or other cardiac disease; hematologic disease; coagulation&#xD;
             disorders (including any abnormal bleeding or blood dyscrasias); lipid abnormalities;&#xD;
             significant pulmonary disease, including bronchospastic respiratory disease; diabetes&#xD;
             mellitus; hepatic or renal insufficiency (creatinine clearance below 60 milliliter per&#xD;
             minute [mL/min]); thyroid disease; neurologic or psychiatric disease; infection; or&#xD;
             any other illness that the Investigator considers should exclude the subject or that&#xD;
             could interfere with the interpretation of the study results&#xD;
&#xD;
          -  Clinically significant abnormal values for hematology, clinical chemistry, or&#xD;
             urinalysis at screening as deemed appropriate by the Investigator&#xD;
&#xD;
          -  Clinically significant abnormal physical examination, vital signs or 12 lead ECG at&#xD;
             screening as deemed appropriate by the Investigator&#xD;
&#xD;
          -  Use of medications or treatments that would significantly influence or exaggerate&#xD;
             patch adhesion or that would alter inflammatory or immune response to the study&#xD;
             product (example, antihistamines, systemic or topical corticosteroids, cyclosporine,&#xD;
             tacrolimus, cytotoxic drugs, immune globulin, Bacillus Calmette-Guerin (BCG),&#xD;
             monoclonal antibodies, radiation therapy)&#xD;
&#xD;
          -  History of drug or alcohol abuse according to Diagnostic and Statistical Manual of&#xD;
             Mental Disorders (4th edition) criteria within 5 years before screening or positive&#xD;
             test result(s) for alcohol and/or drugs of abuse (such as barbiturates, opiates,&#xD;
             cocaine, cannabinoids, amphetamines, and benzodiazepines) at screening&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen Research &amp; Development, LLC Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Research &amp; Development, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Cypress</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>September 12, 2014</last_update_submitted>
  <last_update_submitted_qc>September 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy</keyword>
  <keyword>JNJ-35685-AAA-G-023</keyword>
  <keyword>Placebo</keyword>
  <keyword>Transdermal delivery device system</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tissue Adhesions</mesh_term>
  </condition_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/NCT02221726
org study id: CR105188
secondary id: FENPAI1024
nct id: NCT02221726
lead sponsor: 
The purpose of this study is to assess 3 different scoring systems to evaluate the adhesive
      quality of placebo (an inactive substance that is compared with a drug to test whether the
      drug has a real effect in a clinical trial]) JNJ-35685-AAA-G-023-G transdermal (through the
      skin) systems during a single system 72-hour application, replicated 3 times, of 2 patch
      sizes (5.5 centimeter^2 [cm^2] and 44 cm^2).
This study will assess 3 different scoring systems to evaluate the adhesive quality of
      "placebo" patch (an inactive patch that contains no active drug), JNJ-35685-AAA-G-023-G
      transdermal (through the skin) system. In this study, this patch is NOT being compared to a
      patch with a drug, and is NOT being used to test if the patch with the drug has a real effect
      in a clinical trial. The study consists 3 parts: Screening (21 days before study commences on
      Day 1), an adhesion assessment period (4 days), and an end of Study (EOS) assessment
      (recorded at 24 hours +/- 4 hours following patch removal). Total study duration per
      participant will be 26 days (including Screening). JNJ-35685-AAA-G-023 small (5.5 cm^2) and
      large (44 cm^2) patches will be applied on to left or right side of the paraspinal region
      based on randomization schedule. Adhesion assessments will be performed at patch application
      (hour 0, Baseline), and during the time interval of 8 to 10 hours, 24, 48, and 72 hours
      following patch application. Adhesion quality will be assessed by visual grading, United
      States Food and Drug Administration (FDA) scale, digital image analysis and visual grading
      grid system. Participants' safety will be monitored throughout the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Visual Grading United States Food and Drug Administration (FDA) Scale Score
time frame: Baseline up to 72 hours following patch application
description: Visual grading US FDA scale will be used to evaluate adhesion performance of the transdermal system. The score ranges from 0-4: 0 = greater than or equal to (>=) 90 percent (%) adhered (essentially no lift off the skin); 1 = greater than or equal to 75% to less than (<) 90% adhered (some edges only lifting off the skin); 2 = greater than or equal to 50% to <75% adhered (less than half of the patch lifting off the skin); 3 = greater than (>) 0% to <50% adhered but not detached (more than half of the patch lifting off the skin without falling off); and 4 = 0% adhered - patch detached (patch completely off the skin).
measure: Adhesion Area Calculated by Digital Image Analysis
time frame: Baseline up to 72 hours following patch application
description: Digital image will be captured with high resolution for each transdermal patch site and adhesion area will be calculated.
measure: Total Adhesion Score Calculated by Visual Grading Grid System
time frame: Baseline up to 72 hours following patch application
description: Total adhesion score will be calculated by visual grading grid system (a grid system based on 20 four-sided divisions that are approximately 5% of the total patch area; 44 cm^2 patch will be evaluated by square and rectangular grid elements while 5.5 cm^2 patch will be evaluated by square grid element only) which also contains a scale to allow for proper determination of actual area of the patch not adhering to the skin. Total area of the patch which does not adhere will be calculated. Any area of the patch that does not entirely adhere onto the skin will be scored as 0% adhesion for that area. Subsequently, a total adhesion score for that system will be calculated.
measure: Number of Participants With Adverse Events (AEs) and Serious AEs
time frame: Baseline up to 72 hours following patch application
arm group label: JNJ-35684-AAA-023: 5.5 cm^2 Patch
arm group type: Experimental
arm group label: JNJ-35684-AAA-023: 44 cm^2 Patch
arm group type: Experimental
intervention type: Drug
intervention name: JNJ-35684-AAA-023: Size 1; small patch
description: Placebo (matched to Fentanyl transdermal delivery device system [TDDS]) JNJ-35685-AAA-G-023 TDDS, 5.5 centimeter square (cm^2) will be applied vertically to 1 side of the paraspinal region, replicated 3 times, and worn for 72 hours.
arm group label: JNJ-35684-AAA-023: 5.5 cm^2 Patch
intervention type: Drug
intervention name: JNJ-35684-AAA-023: Size 2; large patch
description: Placebo (matched to Fentanyl transdermal delivery device system [TDDS]) JNJ-35685-AAA-G-023 TDDS, 44 cm^2 (Size 1; small patch) will be applied vertically to other side of the paraspinal region, replicated 3 times, and worn for 72 hours.
arm group label: JNJ-35684-AAA-023: 44 cm^2 Patch
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Janssen Research & Development, LLC Clinical Trial
role: Study Director
affiliation: Janssen Research & Development, LLC
facility: 
country: United States
responsible party type: Sponsor
mesh term: Tissue Adhesions