<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/NCT02227069</url>
  </required_header>
  <id_info>
    <org_study_id>M518101-US06</org_study_id>
    <nct_id>NCT02227069</nct_id>
  </id_info>
  <brief_title>Skin Safety Study to Evaluate the Irritation Potential in Healthy Volunteers</brief_title>
  <official_title>A Phase 1, 21-Day, Randomized, Evaluator Blinded, Controlled Study to Evaluate the Irritation Potential of M518101 in Healthy Volunteers, Using a Cumulative Irritant Patch Test Design</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maruho North America Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maruho North America Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single center, randomized, controlled, within-subject comparison, multiple dose&#xD;
      study to determine the irritation potential of M518101 on normal skin under occlusive patch&#xD;
      condition.&#xD;
&#xD;
      The study drug will be applied for 21 days under occlusive patch condition. The irritation&#xD;
      potential of M518101 will be compared with positive, negative control and M518101 vehicle.&#xD;
      The study duration is 21days and there will be at least 23 visits to study center including&#xD;
      screening visit.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Inflammatory skin responses</measure>
    <time_frame>21 Days</time_frame>
    <description>Drug application sites will be evaluated for signs of inflammatory skin responses (e.g. erythema, edema, papules) and superficial effects.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>M518101</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>M518101 is applied topically under occlusive patch conditions to the infrascapular area of the back, once daily for 21 consecutive days over 3 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>M518101 Vehicle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>M518101 vehicle is applied topically under occlusive patch conditions to the infrascapular area of the back, once daily for 21 consecutive days over 3 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sodium lauryl sulfate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A solution of 0.2% sodium lauryl sulfate is applied topically under occlusive patch conditions to the infrascapular area of the back once daily for 21 days over 3 weeks, will serve as a positive control.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>A solution of 0.9% saline is applied topically under occlusive patch conditions to the infrascapular area of the back once daily for 21 days over 3 weeks, will serve as a negative control.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>M518101</intervention_name>
    <arm_group_label>M518101</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>M518101 Vehicle</intervention_name>
    <arm_group_label>M518101 Vehicle</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>sodium lauryl sulfate</intervention_name>
    <arm_group_label>sodium lauryl sulfate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>saline</intervention_name>
    <arm_group_label>Saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Health male or female subjects age 18 years or older&#xD;
&#xD;
          -  Signed and dated Informed Consent Form obtained prior to any study-related activities&#xD;
&#xD;
          -  Subjects are free of any systemic or dermatologic disorder&#xD;
&#xD;
          -  For Female, females of non-childbearing potential or who agree to use a highly&#xD;
             effective method of birth control during the study and have a negative urine pregnancy&#xD;
             test.&#xD;
&#xD;
          -  Subjects must be able to communicate with the investigator and understand and comply&#xD;
             with the requirements of the study and visit schedule&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have any visible skin disease at the application site which will interfere with the&#xD;
             evaluation of the test site reaction&#xD;
&#xD;
          -  Have damaged skin in or around the test sites&#xD;
&#xD;
          -  Have a history of sensitivity to adhesive tape&#xD;
&#xD;
          -  Have a known sensitivity to constituents present in the material being evaluated&#xD;
&#xD;
          -  Have a history of, or are currently being treated for skin cancer&#xD;
&#xD;
          -  have used any study drug and/or participate in any clinical study within 60 days prior&#xD;
             to Randomization&#xD;
&#xD;
          -  to engage in any type of strenuous exercise (swimming, running, etc.) or who intended&#xD;
             to use hot tubs or saunas during the study&#xD;
&#xD;
          -  Are pregnant, breastfeeding, or of childbearing potential and who wish to become&#xD;
             pregnant during the study&#xD;
&#xD;
          -  Are deemed to be ineligible by the 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>
  <location>
    <facility>
      <name>TKL research</name>
      <address>
        <city>Fair Lawn</city>
        <state>New Jersey</state>
        <zip>07410</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>March 27, 2015</last_update_submitted>
  <last_update_submitted_qc>March 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 30, 2015</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/NCT02227069
org study id: M518101-US06
nct id: NCT02227069
lead sponsor: 
has dmc: No
This is a single center, randomized, controlled, within-subject comparison, multiple dose
      study to determine the irritation potential of M518101 on normal skin under occlusive patch
      condition.

      The study drug will be applied for 21 days under occlusive patch condition. The irritation
      potential of M518101 will be compared with positive, negative control and M518101 vehicle.
      The study duration is 21days and there will be at least 23 visits to study center including
      screening visit.
allocation: Randomized
intervention model: Single Group Assignment
masking: Double (Participant, Outcomes Assessor)
measure: Inflammatory skin responses
time frame: 21 Days
description: Drug application sites will be evaluated for signs of inflammatory skin responses (e.g. erythema, edema, papules) and superficial effects.
arm group label: M518101
arm group type: Experimental
description: M518101 is applied topically under occlusive patch conditions to the infrascapular area of the back, once daily for 21 consecutive days over 3 weeks
arm group label: M518101 Vehicle
arm group type: Placebo Comparator
description: M518101 vehicle is applied topically under occlusive patch conditions to the infrascapular area of the back, once daily for 21 consecutive days over 3 weeks
arm group label: sodium lauryl sulfate
arm group type: Active Comparator
description: A solution of 0.2% sodium lauryl sulfate is applied topically under occlusive patch conditions to the infrascapular area of the back once daily for 21 days over 3 weeks, will serve as a positive control.
arm group label: Saline
arm group type: Sham Comparator
description: A solution of 0.9% saline is applied topically under occlusive patch conditions to the infrascapular area of the back once daily for 21 days over 3 weeks, will serve as a negative control.
intervention type: Drug
intervention name: M518101
arm group label: M518101
intervention type: Drug
intervention name: M518101 Vehicle
arm group label: M518101 Vehicle
intervention type: Other
intervention name: sodium lauryl sulfate
arm group label: sodium lauryl sulfate
intervention type: Other
intervention name: saline
arm group label: Saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor