<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/NCT02256930</url>
  </required_header>
  <id_info>
    <org_study_id>M518101-US07</org_study_id>
    <nct_id>NCT02256930</nct_id>
  </id_info>
  <brief_title>Skin Safety Study to Evaluate the Sensitizing Potential in Healthy Volunteers</brief_title>
  <official_title>A Phase 1, Randomized, Evaluator Blinded, Controlled Study to Evaluate the Sensitizing Potential of M518101 in Healthy Volunteers Using a Repeat Insult 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 sensitization potential of M518101 on normal skin under occlusive&#xD;
      patch condition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During the Induction Phase of the study, the study drugs and controls will be applied 9 times&#xD;
      for 21 days on the infrascapular area of the back under occlusive patch conditions.&#xD;
&#xD;
      Following induction, subjects will have a 10 to 14-day Rest phase, after which they will&#xD;
      enter the challenge Phase, which consists of one 48-hour patch application (occlusive) to a&#xD;
      naïve site on the opposite side of the back.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">November 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 response score</measure>
    <time_frame>21 days</time_frame>
    <description>Drug application site will be evaluated for sign of inflammatory skin response (e.g. erythema, edema, papules)</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">240</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>M518101</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>M518101 will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>M518101 Vehicle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>M518101 Vehicle will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sodium lauryl sulfate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The sodium lauryl sulfate will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The saline will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions.</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 are 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 requirement 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&#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>August 2015</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>August 7, 2015</last_update_submitted>
  <last_update_submitted_qc>August 7, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 11, 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/NCT02256930
org study id: M518101-US07
nct id: NCT02256930
lead sponsor: 
has dmc: No
This is a single center, randomized, controlled, within subject comparison, multiple dose
      study to determine the sensitization potential of M518101 on normal skin under occlusive
      patch condition.
During the Induction Phase of the study, the study drugs and controls will be applied 9 times
      for 21 days on the infrascapular area of the back under occlusive patch conditions.

      Following induction, subjects will have a 10 to 14-day Rest phase, after which they will
      enter the challenge Phase, which consists of one 48-hour patch application (occlusive) to a
      naïve site on the opposite side of the back.
allocation: Randomized
intervention model: Single Group Assignment
masking: Double (Participant, Outcomes Assessor)
measure: inflammatory skin response score
time frame: 21 days
description: Drug application site will be evaluated for sign of inflammatory skin response (e.g. erythema, edema, papules)
arm group label: M518101
arm group type: Experimental
description: M518101 will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions.
arm group label: M518101 Vehicle
arm group type: Placebo Comparator
description: M518101 Vehicle will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions.
arm group label: Sodium lauryl sulfate
arm group type: Active Comparator
description: The sodium lauryl sulfate will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions.
arm group label: Saline
arm group type: Sham Comparator
description: The saline will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions.
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