<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/NCT01688518</url>
  </required_header>
  <id_info>
    <org_study_id>LCR-07-01-101</org_study_id>
    <nct_id>NCT01688518</nct_id>
  </id_info>
  <brief_title>Evaluation of the Depth and Duration of Anesthesia From Heated Lidocaine/Tetracaine (Synera®) Patches Compared With 5% Lidocaine (Lidoderm®) Patches Applied to Healthy Adult Volunteers</brief_title>
  <official_title>Evaluation of the Depth and Duration of Anesthesia From Heated Lidocaine/Tetracaine (Synera®) Patches Compared With 5% Lidocaine (Lidoderm®) Patches Applied to Healthy Adult Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CRI Lifetree</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nuvo Research Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>CRI Lifetree</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This will be a randomized, single-blind, active-controlled, two-period crossover study in&#xD;
      adult volunteers to compare the duration and depth of anesthesia between Synera® and&#xD;
      Lidoderm® patches when applied for 30 minutes and 4 hours. The study will include a Screening&#xD;
      Visit, two Treatment Periods, and a Follow-Up Phone Contact.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">November 2012</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Depth of Anesthesia measured in mm via insertion of 21-gauge needle into the skin.</measure>
    <time_frame>Approximately 5 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of Anesthesia measured in sensory presence, absence, and thermal thresholds.</measure>
    <time_frame>Approximately 5 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Synera® for 30min &amp; Lidoderm® for 4 hours</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Heated Lidocaine/Tetracaine (Synera®)applied to one forearm for either 30 minutes or 4 hours and a 5% Lidocaine (Lidoderm®) patch applied to the alternate forearm for the alternate time period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lidoderm® for 30min &amp; Synera® for 4 hours</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Heated Lidocaine/Tetracaine (Synera®)applied to one forearm for either 30 minutes or 4 hours and a 5% Lidocaine (Lidoderm®) patch applied to the alternate forearm for the alternate time period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Heated Lidocaine/Tetracaine Patch</intervention_name>
    <arm_group_label>Lidoderm® for 30min &amp; Synera® for 4 hours</arm_group_label>
    <arm_group_label>Synera® for 30min &amp; Lidoderm® for 4 hours</arm_group_label>
    <other_name>Synera® Patch</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>5% Lidocaine Patch</intervention_name>
    <arm_group_label>Lidoderm® for 30min &amp; Synera® for 4 hours</arm_group_label>
    <arm_group_label>Synera® for 30min &amp; Lidoderm® for 4 hours</arm_group_label>
    <other_name>Lidoderm® Patch</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion:&#xD;
&#xD;
          1. Subject is male or female 18-60 years of age, inclusive.&#xD;
&#xD;
          2. Subject is judged by the Investigator to be in generally good health at screening&#xD;
             based upon the results of a medical history, physical examination, clinical laboratory&#xD;
             profile, and 12-lead electrocardiogram (ECG).&#xD;
&#xD;
          3. Subject is willing to refrain from using any local topical preparations on the volar&#xD;
             aspect of the forearms for 24 hours prior to each site visit.&#xD;
&#xD;
          4. Subject has normal, intact skin bilaterally at the antecubital area.&#xD;
&#xD;
          5. If female, must be of non-childbearing potential (defined as postmenopausal for at&#xD;
             least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy&#xD;
             or hysterectomy]) or must be using adequate contraception (practicing one of the&#xD;
             following methods of birth control):&#xD;
&#xD;
               -  Total abstinence from sexual intercourse (minimum of one complete menstrual cycle&#xD;
                  before study entry),&#xD;
&#xD;
               -  A vasectomized partner,&#xD;
&#xD;
               -  Contraceptives (oral, parenteral, or transdermal) for 3 consecutive months prior&#xD;
                  to test product administration,&#xD;
&#xD;
               -  Intrauterine device (IUD), or&#xD;
&#xD;
               -  Double-barrier method (condoms, sponge, diaphragm, or vaginal ring with&#xD;
                  spermicidal jellies or cream).&#xD;
&#xD;
          6. If female, must have a negative urine pregnancy test at Screening and at check-in of&#xD;
             each Treatment Period.&#xD;
&#xD;
          7. Subject is willing to be blindfolded during the study and agrees to abide by all study&#xD;
             restrictions and comply with all study procedures.&#xD;
&#xD;
          8. Able to fluently speak and understand English and be able to provide meaningful&#xD;
             written informed consent for the study.&#xD;
&#xD;
        Exclusion:&#xD;
&#xD;
          1. Subject has clinically significant ECG abnormalities at screening.&#xD;
&#xD;
          2. Subject is currently receiving class I, II, or III anti-arrhythmic agents.&#xD;
&#xD;
          3. Subject has used over-the-counter (OTC) or prescription analgesics within 24 hours&#xD;
             prior to either study period.&#xD;
&#xD;
          4. Subject has a known allergy or history of significant adverse reaction to any&#xD;
             component of the treatment or related compounds.&#xD;
&#xD;
          5. Subject has a history of or active use or abuse of illicit drug substance or alcohol&#xD;
             abuse.&#xD;
&#xD;
          6. Subject has a positive urine test result for drugs of abuse or a positive ethanol&#xD;
             breath test at the Screening Visit or check-in to Treatment Visit 1.&#xD;
&#xD;
          7. Subject has active dermatological disease of any origin that may interfere with the&#xD;
             ability to participate.&#xD;
&#xD;
          8. Subject has denuded or broken skin on either forearm.&#xD;
&#xD;
          9. Subject has a history of unstable peripheral/vascular disease and/or hypertensive&#xD;
             vascular disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Miroslav Backonja, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CRI Lifetree</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lifetree Clinical Research</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2013</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 20, 2012</study_first_posted>
  <last_update_submitted>January 2, 2013</last_update_submitted>
  <last_update_submitted_qc>January 2, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Evaluation</keyword>
  <keyword>Depth and Duration</keyword>
  <keyword>Anesthesia</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Tetracaine</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/NCT01688518
org study id: LCR-07-01-101
nct id: NCT01688518
lead sponsor: 
collaborator: 
has dmc: Yes
This will be a randomized, single-blind, active-controlled, two-period crossover study in
      adult volunteers to compare the duration and depth of anesthesia between Synera® and
      Lidoderm® patches when applied for 30 minutes and 4 hours. The study will include a Screening
      Visit, two Treatment Periods, and a Follow-Up Phone Contact.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Depth of Anesthesia measured in mm via insertion of 21-gauge needle into the skin.
time frame: Approximately 5 months
measure: Duration of Anesthesia measured in sensory presence, absence, and thermal thresholds.
time frame: Approximately 5 months
arm group label: Synera® for 30min & Lidoderm® for 4 hours
arm group type: Active Comparator
description: Heated Lidocaine/Tetracaine (Synera®)applied to one forearm for either 30 minutes or 4 hours and a 5% Lidocaine (Lidoderm®) patch applied to the alternate forearm for the alternate time period.
arm group label: Lidoderm® for 30min & Synera® for 4 hours
arm group type: Active Comparator
description: Heated Lidocaine/Tetracaine (Synera®)applied to one forearm for either 30 minutes or 4 hours and a 5% Lidocaine (Lidoderm®) patch applied to the alternate forearm for the alternate time period.
intervention type: Drug
intervention name: Heated Lidocaine/Tetracaine Patch
arm group label: Lidoderm® for 30min & Synera® for 4 hours
arm group label: Synera® for 30min & Lidoderm® for 4 hours
other name: Synera® Patch
intervention type: Drug
intervention name: 5% Lidocaine Patch
arm group label: Lidoderm® for 30min & Synera® for 4 hours
arm group label: Synera® for 30min & Lidoderm® for 4 hours
other name: Lidoderm® Patch
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Miroslav Backonja, MD
role: Principal Investigator
affiliation: CRI Lifetree
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lidocaine
mesh term: Tetracaine