<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/NCT01670032</url>
  </required_header>
  <id_info>
    <org_study_id>RD.06. SPR. 18216</org_study_id>
    <nct_id>NCT01670032</nct_id>
  </id_info>
  <brief_title>Vehicle Controlled Efficacy and Safety Study of Two Dose Regimens of CD07223 1.5% Topical Gel in Impetigo</brief_title>
  <official_title>A Multicenter, Double Blind, Randomized, Vehicle Controlled Study to Evaluate the Efficacy and Safety of Two Dose Regimens of CD 07223 1.5% Topical Gel in Impetigo</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NovaBay Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NovaBay Pharmaceuticals, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will be a multicenter, randomized, vehicle controlled, parallel, group, double&#xD;
      blind study. Eligible subjects with a clinical diagnosis of impetigo will be randomized to&#xD;
      one of four treatment groups: 1.5% CD07223 Topical Gel applied BID; 1.5% CD07223 Topical Gel&#xD;
      applied TID; Vehicle Topical Gel applied BID;Vehicle Topical Gel applied TID. All treatments&#xD;
      will be administered for 7 days. Disease activity for the Target Lesion will be evaluated&#xD;
      using the Skin Infection Rating Scale (SIRS) Score.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</primary_completion_date>
  <phase>Phase 2/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>Clinical Success at Follow up (Day 15) in the intent-to-treat (ITTC) population</measure>
    <time_frame>2 weeks</time_frame>
    <description>Clinical Success is defined by the SIRS score of the Target Lesion</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">328</enrollment>
  <condition>Impetigo</condition>
  <arm_group>
    <arm_group_label>CD07223 1.5 % Topical Gel BID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: 1.5% CD07223 Topical Gel applied BID for 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CD07223 1.5% Topical Gel TID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: 1.5% CD07223 Topical Gel applied TID for 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CD07223 vehicle gel BID</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Drug: CD07223 Vehicle Topical Gel applied BID for 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CD07223 vehicle gel TID</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Drug: CD07223 Vehicle Topical Gel applied TID for 7 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Experimental: CD07223 1.5 % Topical Gel BID</intervention_name>
    <description>Eligible subjects are to apply study medication twice a day (BID) for seven days. All lesions will be treated with study medication. Scheduled study visits will occur at Day 1, Day 3, Day 8 and Day 15</description>
    <arm_group_label>CD07223 1.5 % Topical Gel BID</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Experimental: CD07223 1.5% Topical Gel TID</intervention_name>
    <description>Eligible subjects are to apply study medication three times a day (TID) for seven days. All lesions will be treated with study medication. Scheduled study visits will occur at Day 1, Day 3, Day 8 and Day 15</description>
    <arm_group_label>CD07223 1.5% Topical Gel TID</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Comparator: CD07223 vehicle gel BID</intervention_name>
    <description>Eligible subjects are to apply study medication twice a day (BID) for seven days. All lesions will be treated with study medication. Scheduled study visits will occur at Day 1, Day 3, Day 8 and Day 15</description>
    <arm_group_label>CD07223 vehicle gel BID</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Comparator: CD07223 vehicle gel TID</intervention_name>
    <description>Eligible subjects are to apply study medication three times a day (TID) for seven days. All lesions will be treated with study medication. Scheduled study visits will occur at Day 1, Day 3, Day 8 and Day 15</description>
    <arm_group_label>CD07223 vehicle gel TID</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female 2 years of age or older&#xD;
&#xD;
          -  Clinical diagnosis of primary impetigo (bullous or non bullous)&#xD;
&#xD;
          -  Minimum diameter of Target Lesion to be one centimeter measured either as length or&#xD;
             width.&#xD;
&#xD;
          -  Presence of at least one and no more than ten lesions per subject at the time of&#xD;
             screening&#xD;
&#xD;
          -  The infected lesions' total area (as determined by the Investigator) must be less than&#xD;
             100 cm2 in total area for subjects 18 years of age or older, or up to a maximum of 2%&#xD;
             total body surface area for subjects younger than 18 years of age.&#xD;
&#xD;
          -  Skin Infection Rating Scale (SIRS) total score of the Target Lesion of at least 4&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of other active skin diseases at or near the Target Lesion area to be treated&#xD;
&#xD;
          -  A subject whose disease is so widespread or severe that, in the opinion of the&#xD;
             investigator, oral antibiotic treatment is needed&#xD;
&#xD;
          -  Signs and symptoms of another current infection requiring antibiotic treatment&#xD;
&#xD;
          -  Tympanic temperature at Screening/Baseline exceeding 38 degrees Celsius (100.4 degrees&#xD;
             Fahrenheit) in a pediatric subject or 37.8 degrees Celsius (100 degrees Fahrenheit) in&#xD;
             an adult subject&#xD;
&#xD;
          -  History of Hepatitis B or C, HIV/ AIDS, or other immunodeficiency disease&#xD;
&#xD;
          -  Concurrent or recent scabies infection or lice infestation (pediculosis) of the scalp&#xD;
&#xD;
          -  Use of systemic antibiotics or systemic steroids within 14 days prior to study entry.&#xD;
             A history of three or more courses of systemic antibiotics within the 3 month period&#xD;
             immediately prior to screening will also be considered exclusionary&#xD;
&#xD;
          -  Use of topical antibiotics, topical antibacterials, topical antifungals or topical&#xD;
             steroids within 14 days prior to study entry on any skin lesion (as deemed significant&#xD;
             by the Investigator by virtue of the lesion's nature and/or position to impact on the&#xD;
             effectiveness of the study drug)&#xD;
&#xD;
          -  Participation in any other clinical study or use of any investigational drugs or&#xD;
             investigational device within 30 days prior to enrollment&#xD;
&#xD;
          -  Presence of secondarily infected traumatic lesions (e.g. surgical wounds,&#xD;
             animal/insect bites, burns, lacerations and abrasions).&#xD;
&#xD;
          -  Another family member in same household currently enrolled in this study or another&#xD;
             family member in the same household with active impetigo&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>SRCR, Inc</name>
      <address>
        <city>Bell Gardens</city>
        <state>California</state>
        <zip>90201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skin Care research Inc</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eastern Research, Inc</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33013</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cyn3rgy Research</name>
      <address>
        <city>Gresham</city>
        <state>Oregon</state>
        <zip>97030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cheraw Pediatrics, P.A.</name>
      <address>
        <city>Cheraw</city>
        <state>South Carolina</state>
        <zip>29520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Integrity Clinical Research, Inc</name>
      <address>
        <city>Milan</city>
        <state>Tennessee</state>
        <zip>38358</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sealy Urgent Care Center</name>
      <address>
        <city>Sealy</city>
        <state>Texas</state>
        <zip>77474</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Langeberg Clinical Trials</name>
      <address>
        <city>Kraaifontein</city>
        <state>Cape Town</state>
        <zip>7570</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Newtown Clinical Research</name>
      <address>
        <city>Johannesburg</city>
        <state>Gauteng</state>
        <zip>2113</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Phelang Research Center</name>
      <address>
        <city>Pretoria</city>
        <state>Gauteng</state>
        <zip>0122</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Setshaba Research Center</name>
      <address>
        <city>Soshanguve</city>
        <state>Gauteng</state>
        <zip>0152</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Welkom Clinical Trial Center</name>
      <address>
        <city>Welkom</city>
        <state>Gauteng</state>
        <zip>9460</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synopsis Research</name>
      <address>
        <city>Rondebosch</city>
        <state>Western Cape</state>
        <zip>7700</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>South Africa</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 17, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <disposition_first_submitted>August 7, 2014</disposition_first_submitted>
  <disposition_first_submitted_qc>August 8, 2014</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">August 12, 2014</disposition_first_posted>
  <last_update_submitted>August 8, 2014</last_update_submitted>
  <last_update_submitted_qc>August 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 12, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Impetigo</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT01670032
org study id: RD.06. SPR. 18216
nct id: NCT01670032
lead sponsor: 
has dmc: No
This study will be a multicenter, randomized, vehicle controlled, parallel, group, double
      blind study. Eligible subjects with a clinical diagnosis of impetigo will be randomized to
      one of four treatment groups: 1.5% CD07223 Topical Gel applied BID; 1.5% CD07223 Topical Gel
      applied TID; Vehicle Topical Gel applied BID;Vehicle Topical Gel applied TID. All treatments
      will be administered for 7 days. Disease activity for the Target Lesion will be evaluated
      using the Skin Infection Rating Scale (SIRS) Score.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Clinical Success at Follow up (Day 15) in the intent-to-treat (ITTC) population
time frame: 2 weeks
description: Clinical Success is defined by the SIRS score of the Target Lesion
arm group label: CD07223 1.5 % Topical Gel BID
arm group type: Experimental
description: Drug: 1.5% CD07223 Topical Gel applied BID for 7 days
arm group label: CD07223 1.5% Topical Gel TID
arm group type: Experimental
description: Drug: 1.5% CD07223 Topical Gel applied TID for 7 days
arm group label: CD07223 vehicle gel BID
arm group type: Placebo Comparator
description: Drug: CD07223 Vehicle Topical Gel applied BID for 7 days
arm group label: CD07223 vehicle gel TID
arm group type: Placebo Comparator
description: Drug: CD07223 Vehicle Topical Gel applied TID for 7 days
intervention type: Drug
intervention name: Experimental: CD07223 1.5 % Topical Gel BID
description: Eligible subjects are to apply study medication twice a day (BID) for seven days. All lesions will be treated with study medication. Scheduled study visits will occur at Day 1, Day 3, Day 8 and Day 15
arm group label: CD07223 1.5 % Topical Gel BID
intervention type: Drug
intervention name: Experimental: CD07223 1.5% Topical Gel TID
description: Eligible subjects are to apply study medication three times a day (TID) for seven days. All lesions will be treated with study medication. Scheduled study visits will occur at Day 1, Day 3, Day 8 and Day 15
arm group label: CD07223 1.5% Topical Gel TID
intervention type: Drug
intervention name: Placebo Comparator: CD07223 vehicle gel BID
description: Eligible subjects are to apply study medication twice a day (BID) for seven days. All lesions will be treated with study medication. Scheduled study visits will occur at Day 1, Day 3, Day 8 and Day 15
arm group label: CD07223 vehicle gel BID
intervention type: Drug
intervention name: Placebo Comparator: CD07223 vehicle gel TID
description: Eligible subjects are to apply study medication three times a day (TID) for seven days. All lesions will be treated with study medication. Scheduled study visits will occur at Day 1, Day 3, Day 8 and Day 15
arm group label: CD07223 vehicle gel TID
criteria: 
gender: All
minimum age: 2 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
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facility: 
facility: 
country: South Africa
country: United States
responsible party type: Sponsor
mesh term: Impetigo