<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/NCT01695187</url>
  </required_header>
  <id_info>
    <org_study_id>NB-001-010</org_study_id>
    <nct_id>NCT01695187</nct_id>
  </id_info>
  <brief_title>NB-001 Treatment of Recurrent Herpes Labialis</brief_title>
  <official_title>A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study of NB-001 Treatment of Recurrent Herpes Labialis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NanoBio Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NanoBio Corporation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a study to test the hypothesis that time to healing of a cold sore will be lower in&#xD;
      the active treatment arm of the study when compared to the vehicle (placebo). Subjects with a&#xD;
      history of cold sores will be enrolled and administered active treatment or placebo in a&#xD;
      blinded manner. Subjects will then be followed to assess time to healing.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">July 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <phase>Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to healing of the primary lesion complex (in days or fraction thereof) as assessed by the investigator.</measure>
    <time_frame>Time to healing will be assessed from treatment onset to resolution of symptoms (maximum of 16 days)</time_frame>
    <description>Time to healing is the time from receiving the combination to unlock the medication and begin treatment to investigator assessed healing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects in whom the primary lesion complex does not progress beyond the Papule/Edema Stage</measure>
    <time_frame>Proportion of subjects in whom the primary lesion complex does not progress will be assessed from treatment onset to resolution of symptoms (maximum of 16 days)</time_frame>
    <description>This analysis will be performed in the cohort of subjects whose primary lesion complex is assessed as being in the Prodrome (pain, burning, tingling, itching, redness, swelling, or a tight sensation of the lip), Erythema/Macule, Papule/Edema, or Aborted Stage by the investigator at the first post-treatment visit.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Safety and tolerability</measure>
    <time_frame>Safety and tolerability will be assessed from treatment onset to study close (expected average of 2 months)</time_frame>
    <description>Safety and tolerability of NB-001 following topical administration as assessed by the number and severity of adverse events.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">362</enrollment>
  <condition>Herpes Labialis</condition>
  <arm_group>
    <arm_group_label>NB-001 (0.3%)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NB-001 is an oil-in-water emulsion composed of nanometer-sized, positively charged droplets (average particle size = 180nm). NB-001 is composed of highly refined soybean oil, purified water, ethanol, edetate disodium dihydrate (EDTA) and two surfactants: polysorbate (Tween) 20 and cetylpyridinium chloride (CPC).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>NB-001 is an oil-in-water emulsion composed of nanometer-sized, positively charged droplets (average particle size = 180nm). NB-001 is composed of highly refined soybean oil, purified water, ethanol, edetate disodium dihydrate (EDTA) and one surfactant: polysorbate (Tween) 20.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NB-001 (0.3%)</intervention_name>
    <description>Topical administration at least five times throughout the day</description>
    <arm_group_label>NB-001 (0.3%)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Vehicle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Be a healthy man or woman 18 years of age or older. Women who are pregnant, lactating&#xD;
             or may become pregnant may (at the investigator's discretion) be included in the&#xD;
             study;&#xD;
&#xD;
          2. Have recurrent herpes labialis as defined by a history of three (3) or more cold sore&#xD;
             recurrences on the lips and/or skin surrounding the lips in the previous year. The&#xD;
             majority of their cold sore recurrences proceeded by a well-defined history of&#xD;
             prodromal symptoms including redness, pain, burning, tingling, itching, swelling or a&#xD;
             tight sensation of the lip at the site of the outbreak;&#xD;
&#xD;
          3. Be willing to refrain from using systemic or topical antiviral agents or systemic&#xD;
             corticosteroids within 4 weeks prior to study drug administration and for the duration&#xD;
             of the cold sore recurrence;&#xD;
&#xD;
          4. Be willing to refrain from using any topical pharmaceutical or cosmetic products other&#xD;
             than the study medication in or around the nasal and perioral areas for the duration&#xD;
             of the cold sore recurrence;&#xD;
&#xD;
          5. Be willing to refrain from participation in another clinical trial;&#xD;
&#xD;
          6. Be willing and able to use phone or internet to obtain the combination to unlock their&#xD;
             study medication kit;&#xD;
&#xD;
          7. Be able to read and write in English and understand and comply with the protocol&#xD;
             requirements;&#xD;
&#xD;
          8. Be able to give informed consent and have signed a written informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known hypersensitivity to one of the drug ingredients, including soybean oil,&#xD;
             polysorbate (Tween), alcohol, EDTA, or cetylpyridinium chloride (found in some&#xD;
             mouthwashes and lozenges);&#xD;
&#xD;
          2. Severe chronic illness including renal failure, severe respiratory or cardiac disease,&#xD;
             chronic infections, immunodeficiency syndrome, uncontrolled diabetes mellitus or&#xD;
             untreated severe thyroid disease;&#xD;
&#xD;
          3. Received (within the last 6 months) or receiving chemotherapy;&#xD;
&#xD;
          4. Significant skin disease on the face (such as atopic dermatitis, cystic acne, severe&#xD;
             rosacea, eczema, psoriasis or other chronic vesiculobullous disorders) or lesions,&#xD;
             wounds, abrasions, piercings, tattoos, irritation or other skin conditions on or&#xD;
             around the nasal and perioral areas that would interfere with the treatment or&#xD;
             assessment of the primary lesion complex. Subjects with mild controlled psoriasis,&#xD;
             eczema, acne or dermatitis or other conditions may be included if the condition does&#xD;
             not interfere with the ability to evaluate a herpes labialis lesion or local skin&#xD;
             irritation;&#xD;
&#xD;
          5. Previously received herpes vaccine;&#xD;
&#xD;
          6. Active alcohol or drug abuse;&#xD;
&#xD;
          7. Prior randomization into any NanoBio study;&#xD;
&#xD;
          8. Any condition that would potentially make them unable to participate for the entire&#xD;
             trial period;&#xD;
&#xD;
          9. Known allergies to topical creams, ointments or other topical medications.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Radiant Research, Inc</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research, Inc</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research, Inc. Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60654</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Kentucky Research Associates, Inc.</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40509</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research, Inc.</name>
      <address>
        <city>Edina</city>
        <state>Minnesota</state>
        <zip>55435</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Center for Pharmaceutical Research, P.C.</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research, Inc.</name>
      <address>
        <city>St. Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research, Inc.</name>
      <address>
        <city>Anderson</city>
        <state>South Carolina</state>
        <zip>29621</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Carolina Research Center</name>
      <address>
        <city>Mt. Pleasant</city>
        <state>South Carolina</state>
        <zip>29464</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Across America</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research, Inc.</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New River Valley Research Institute</name>
      <address>
        <city>Christiansburg</city>
        <state>Virginia</state>
        <zip>24073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>September 18, 2012</study_first_submitted>
  <study_first_submitted_qc>September 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>June 13, 2013</last_update_submitted>
  <last_update_submitted_qc>June 13, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 14, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Herpes, Herpes Labialis, nanoemulsion, NanoBio, NB-001</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Herpes Simplex</mesh_term>
    <mesh_term>Herpes Labialis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>5-((2-(6-Amino-9H-purin-9-yl) ethyl) amino)-1-pentanol</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/NCT01695187
org study id: NB-001-010
nct id: NCT01695187
lead sponsor: 
has dmc: Yes
This is a study to test the hypothesis that time to healing of a cold sore will be lower in
      the active treatment arm of the study when compared to the vehicle (placebo). Subjects with a
      history of cold sores will be enrolled and administered active treatment or placebo in a
      blinded manner. Subjects will then be followed to assess time to healing.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Time to healing of the primary lesion complex (in days or fraction thereof) as assessed by the investigator.
time frame: Time to healing will be assessed from treatment onset to resolution of symptoms (maximum of 16 days)
description: Time to healing is the time from receiving the combination to unlock the medication and begin treatment to investigator assessed healing.
measure: Proportion of subjects in whom the primary lesion complex does not progress beyond the Papule/Edema Stage
time frame: Proportion of subjects in whom the primary lesion complex does not progress will be assessed from treatment onset to resolution of symptoms (maximum of 16 days)
description: This analysis will be performed in the cohort of subjects whose primary lesion complex is assessed as being in the Prodrome (pain, burning, tingling, itching, redness, swelling, or a tight sensation of the lip), Erythema/Macule, Papule/Edema, or Aborted Stage by the investigator at the first post-treatment visit.
measure: Safety and tolerability
time frame: Safety and tolerability will be assessed from treatment onset to study close (expected average of 2 months)
description: Safety and tolerability of NB-001 following topical administration as assessed by the number and severity of adverse events.
arm group label: NB-001 (0.3%)
arm group type: Experimental
description: NB-001 is an oil-in-water emulsion composed of nanometer-sized, positively charged droplets (average particle size = 180nm). NB-001 is composed of highly refined soybean oil, purified water, ethanol, edetate disodium dihydrate (EDTA) and two surfactants: polysorbate (Tween) 20 and cetylpyridinium chloride (CPC).
arm group label: Vehicle
arm group type: Placebo Comparator
description: NB-001 is an oil-in-water emulsion composed of nanometer-sized, positively charged droplets (average particle size = 180nm). NB-001 is composed of highly refined soybean oil, purified water, ethanol, edetate disodium dihydrate (EDTA) and one surfactant: polysorbate (Tween) 20.
intervention type: Drug
intervention name: NB-001 (0.3%)
description: Topical administration at least five times throughout the day
arm group label: NB-001 (0.3%)
intervention type: Drug
intervention name: Placebo
arm group label: Vehicle
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Herpes Simplex
mesh term: Herpes Labialis
mesh term: 5-((2-(6-Amino-9H-purin-9-yl) ethyl) amino)-1-pentanol