<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/NCT02192203</url>
  </required_header>
  <id_info>
    <org_study_id>202186</org_study_id>
    <secondary_id>RH02169</secondary_id>
    <nct_id>NCT02192203</nct_id>
  </id_info>
  <brief_title>A Safety Study to Investigate the Skin Sensitization Potential of MFC51123</brief_title>
  <official_title>Safety Study to Investigate the Skin Sensitization Potential of MFC51123</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research study is being carried out to determine the possibility that a new medication&#xD;
      causes allergic reactions. This new medication contains two active ingredients (diclofenac&#xD;
      and menthol) together in a gel and is being developed to treat mild to moderate pain and&#xD;
      inflammation, such as acute sport injuries, and sprains and strains. Approximately 240&#xD;
      participants will have the medication (gel) applied to the skin on a small area of the upper&#xD;
      back for approximately 48-hour or 72-hour periods over the course of six weeks. Participation&#xD;
      in this research study is voluntary, requiring participants to visit the study clinic on 17&#xD;
      occasions for about 45 minutes each visit. During the visits, doctors or trained staff&#xD;
      members will examine the amount of redness, swelling, and other signs of irritation (if any)&#xD;
      of the skin where the medication (gel) was applied.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2014</start_date>
  <completion_date type="Actual">July 15, 2014</completion_date>
  <primary_completion_date type="Actual">July 15, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Skin irritation</measure>
    <time_frame>At least 23 days but not more than 30 days for induction and challenge phases combined</time_frame>
    <description>During the Induction Phase, the test article and three controls will be applied to adjacent treatment sites on the infrascapular area of the back for nine 48-hour patch applications. Evaluation of dermal reactions at the application sites will be conducted clinically using a visual scale that rates the degree of erythema, edema, and other signs of cutaneous irritation at nine intervals spaced approximately 48-72 hours apart. Following the Induction Phase participants will return to the clinic to begin the Challenge Phase after 12 to 14- day rest phase. The Challenge Phase will consist of one 48-hour patch application to a naive site on the opposite side of the back. Evaluations of dermal reactions at the application sites will be conducted clinically during the Challenge Phase using the same visual scale at 30 minutes, 24 hours, 48 hours, and 72 hours after removal of the challenge patch.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effects on Superficial Layers of the Skin</measure>
    <time_frame>At least 23 days but not more than 30 days for induction and challenge phases combined</time_frame>
    <description>The responses will be assessed using symbol (A-H) and grade (0 -3) scale for each of the four test products: A 0 Slight glazed appearance; C 1 Marked glazing; E 2 Glazing with peeling and cracking; F 3 Glazing with fissures; G 3 Film of dried serous exudate covering all or portion of the patch; H 3 Small petechial erosions and/or scabs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response notation</measure>
    <time_frame>At least 23 days but not more than 30 days for induction and challenge phases combined</time_frame>
    <description>Notations will be made in place of a score to designate particular circumstances preventing the assignment of a score or in addition to a score to identify damage to the epidermis and/or spreading of a reaction beyond the patch site.S: Spreading of reaction beyond patch study site (i.e., reaction where study material was not in contact with the skin); B: Burning or stinging sensation; P: Papular response &gt;50%; Pv: Papulovesicular response &gt;50%; D: Damage to epidermis: oozing, crusting and/or superficial erosions; I; Itching; X: absent Subject absent; PD: Patch dislodged; NA Not applied; NP: Not patched (due to reaction achieved); N9G: No ninth grading</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">227</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Diclofenac + Menthol Gel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1% diclofenac, 3% menthol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diclofenac Only Gel</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1% diclofenac, 0.09% menthol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Menthol Only Gel</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>3% menthol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Only Gel</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>0.09% menthol</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diclofenac + Menthol Gel</intervention_name>
    <description>1% diclofenac, 3% menthol</description>
    <arm_group_label>Diclofenac + Menthol Gel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diclofenac Only Gel</intervention_name>
    <description>1% diclofenac, 0.09% menthol</description>
    <arm_group_label>Diclofenac Only Gel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Menthol Only Gel</intervention_name>
    <description>3% menthol</description>
    <arm_group_label>Menthol Only Gel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Only Gel</intervention_name>
    <description>0.09% menthol</description>
    <arm_group_label>Placebo Only Gel</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy men or women participants with 18 years of age or older.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with a history of hypersensitivity, allergy with the use of NSAIDs or&#xD;
             menthol or currently receiving systemic or topical NSAIDs within 3 days of visit 1.&#xD;
&#xD;
          -  Participants having psoriasis and/or active atopic dermatitis/eczema, and skin&#xD;
             infected.&#xD;
&#xD;
          -  Lesions, burn or wound in the application site.&#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>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>TKL Research Inc</name>
      <address>
        <city>Paramus</city>
        <state>New Jersey</state>
        <zip>07652</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>May 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>June 27, 2017</last_update_submitted>
  <last_update_submitted_qc>June 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diclofenac</mesh_term>
    <mesh_term>Menthol</mesh_term>
  </intervention_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/NCT02192203
org study id: 202186
secondary id: RH02169
nct id: NCT02192203
lead sponsor: 
has dmc: No
This research study is being carried out to determine the possibility that a new medication
      causes allergic reactions. This new medication contains two active ingredients (diclofenac
      and menthol) together in a gel and is being developed to treat mild to moderate pain and
      inflammation, such as acute sport injuries, and sprains and strains. Approximately 240
      participants will have the medication (gel) applied to the skin on a small area of the upper
      back for approximately 48-hour or 72-hour periods over the course of six weeks. Participation
      in this research study is voluntary, requiring participants to visit the study clinic on 17
      occasions for about 45 minutes each visit. During the visits, doctors or trained staff
      members will examine the amount of redness, swelling, and other signs of irritation (if any)
      of the skin where the medication (gel) was applied.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Skin irritation
time frame: At least 23 days but not more than 30 days for induction and challenge phases combined
description: During the Induction Phase, the test article and three controls will be applied to adjacent treatment sites on the infrascapular area of the back for nine 48-hour patch applications. Evaluation of dermal reactions at the application sites will be conducted clinically using a visual scale that rates the degree of erythema, edema, and other signs of cutaneous irritation at nine intervals spaced approximately 48-72 hours apart. Following the Induction Phase participants will return to the clinic to begin the Challenge Phase after 12 to 14- day rest phase. The Challenge Phase will consist of one 48-hour patch application to a naive site on the opposite side of the back. Evaluations of dermal reactions at the application sites will be conducted clinically during the Challenge Phase using the same visual scale at 30 minutes, 24 hours, 48 hours, and 72 hours after removal of the challenge patch.
measure: Effects on Superficial Layers of the Skin
time frame: At least 23 days but not more than 30 days for induction and challenge phases combined
description: The responses will be assessed using symbol (A-H) and grade (0 -3) scale for each of the four test products: A 0 Slight glazed appearance; C 1 Marked glazing; E 2 Glazing with peeling and cracking; F 3 Glazing with fissures; G 3 Film of dried serous exudate covering all or portion of the patch; H 3 Small petechial erosions and/or scabs
measure: Response notation
time frame: At least 23 days but not more than 30 days for induction and challenge phases combined
description: Notations will be made in place of a score to designate particular circumstances preventing the assignment of a score or in addition to a score to identify damage to the epidermis and/or spreading of a reaction beyond the patch site.S: Spreading of reaction beyond patch study site (i.e., reaction where study material was not in contact with the skin); B: Burning or stinging sensation; P: Papular response >50%; Pv: Papulovesicular response >50%; D: Damage to epidermis: oozing, crusting and/or superficial erosions; I; Itching; X: absent Subject absent; PD: Patch dislodged; NA Not applied; NP: Not patched (due to reaction achieved); N9G: No ninth grading
arm group label: Diclofenac + Menthol Gel
arm group type: Experimental
description: 1% diclofenac, 3% menthol
arm group label: Diclofenac Only Gel
arm group type: Active Comparator
description: 1% diclofenac, 0.09% menthol
arm group label: Menthol Only Gel
arm group type: Active Comparator
description: 3% menthol
arm group label: Placebo Only Gel
arm group type: Placebo Comparator
description: 0.09% menthol
intervention type: Drug
intervention name: Diclofenac + Menthol Gel
description: 1% diclofenac, 3% menthol
arm group label: Diclofenac + Menthol Gel
intervention type: Drug
intervention name: Diclofenac Only Gel
description: 1% diclofenac, 0.09% menthol
arm group label: Diclofenac Only Gel
intervention type: Drug
intervention name: Menthol Only Gel
description: 3% menthol
arm group label: Menthol Only Gel
intervention type: Drug
intervention name: Placebo Only Gel
description: 0.09% menthol
arm group label: Placebo Only Gel
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diclofenac
mesh term: Menthol