<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/NCT02990013</url>
  </required_header>
  <id_info>
    <org_study_id>20160881</org_study_id>
    <nct_id>NCT02990013</nct_id>
  </id_info>
  <brief_title>AvenovaTM as a Sterile Skin Preparation Agent</brief_title>
  <official_title>Comparison of Antimicrobial Activity of AvenovaTM as a Sterile Skin Preparation in Humans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Miami</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim 1: To determine in vivo capability of AvenovaTM against common cutaneous microbial biome&#xD;
      on human skin&#xD;
&#xD;
      Aim 2: To compare to povidone-iodine 5% solution, 4% chlorhexidine and isopropyl alcohol&#xD;
      against AvenovaTM as a sterile skin agent&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of approximately 30 eligible participants will be identified with clinically-acquired&#xD;
      information by Dr. Wendy Lee, an oculoplastic surgeon and aesthetic treatment specialist at&#xD;
      Bascom Palmer Eye Institute, during regular clinic visits.&#xD;
&#xD;
      Part One: Patients will have their skin swabbed and then cultured for various skin flora&#xD;
      agents. The petri dish will then be swabbed with Avenova to see what percent of skin flora&#xD;
      microbe is killed.&#xD;
&#xD;
      Part Two: Patients will have their skin divided into 4 quadrants. The area will be&#xD;
      pre-swabbed to monitor microbe growth. Each of 4 quadrants will be cleansed for one minute&#xD;
      with AvenovaTM , povidone-iodine 5% solution, 4% chlorhexidine and isopropyl alcohol, then&#xD;
      swabbed to monitor for microbe growth.&#xD;
&#xD;
      The swabs will be placed in thioglycollate broth to monitor for bacterial growth. If growth&#xD;
      if observed in the thioglycollate, the samples will be cultured on blood agar plates and the&#xD;
      bacterial specie(s) identified.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">December 20, 2019</completion_date>
  <primary_completion_date type="Actual">December 20, 2019</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Compare the efficacy of Avenova to other standard of care cleansing agents: growth vs. no growth</measure>
    <time_frame>12 months</time_frame>
    <description>Growth or no growth of bacteria in the thioglycollate broth will be noted for the control and each quadrant after cleansing with the 4 agents listed above.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bacterial Identification</measure>
    <time_frame>12 months</time_frame>
    <description>Positive thioglycollate samples will be cultured on blood agar plates and the bacterial species then identified.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Cleaning Product Causing Toxic Effect</condition>
  <arm_group>
    <arm_group_label>Treatment arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients will be in the treatment arm where they will be subject to skin testing with various cleansing agents: AvenovaTM , povidone-iodine 5% solution, 4% chlorhexidine and isopropyl alcohol</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Avenova</intervention_name>
    <description>Subjects will all undergo the treatment arm where their skin will be cleansed with four different agents: AvenovaTM , povidone-iodine 5% solution, 4% chlorhexidine and isopropyl alcohol</description>
    <arm_group_label>Treatment arm</arm_group_label>
    <other_name>hypochlorous acid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Povidone-iodine 5% solution</intervention_name>
    <description>Subjects will all undergo the treatment arm where their skin will be cleansed with four different agents: AvenovaTM , povidone-iodine 5% solution, 4% chlorhexidine and isopropyl alcohol</description>
    <arm_group_label>Treatment arm</arm_group_label>
    <other_name>Betadine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>4% chlorhexidine</intervention_name>
    <description>Subjects will all undergo the treatment arm where their skin will be cleansed with four different agents: AvenovaTM , povidone-iodine 5% solution, 4% chlorhexidine and isopropyl alcohol</description>
    <arm_group_label>Treatment arm</arm_group_label>
    <other_name>No other names</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Isopropyl alcohol</intervention_name>
    <description>Subjects will all undergo the treatment arm where their skin will be cleansed with four different agents: AvenovaTM , povidone-iodine 5% solution, 4% chlorhexidine and isopropyl alcohol</description>
    <arm_group_label>Treatment arm</arm_group_label>
    <other_name>No other names</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults age 18 and above able to provide informed consent to participate Adults&#xD;
             attending Dr. Wendy Lee Oculoplastics Clinic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Adults unable to consent&#xD;
&#xD;
          -  Individuals who less than 18 years of age&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Pregnant women - while these cleansing agents are used on pregnant women as standard&#xD;
             cleansing agents, effects to fetus unknown&#xD;
&#xD;
          -  Patients currently using oral or topical antimicrobial agents&#xD;
&#xD;
          -  History of skin infection to facial injectable of surgery&#xD;
&#xD;
          -  Inability to tolerate cleansing procedure&#xD;
&#xD;
          -  Inability to sit comfortably for 15 - 30 minutes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wendy Lee</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bascom Palmer Eye Institute University of Miami, Miller School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Miami Bascom Palmer Eye Institute</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Collins LK, Knackstedt TJ, Samie FH. Antiseptic use in Mohs and reconstructive surgery: an American College of Mohs Surgery member survey. Dermatol Surg. 2015 Jan;41(1):164-6. doi: 10.1097/DSS.0000000000000202. No abstract available.</citation>
    <PMID>25521104</PMID>
  </reference>
  <reference>
    <citation>Steinsapir KD, Woodward JA. Chlorhexidine Keratitis: Safety of Chlorhexidine as a Facial Antiseptic. Dermatol Surg. 2017 Jan;43(1):1-6. doi: 10.1097/DSS.0000000000000822.</citation>
    <PMID>27399954</PMID>
  </reference>
  <reference>
    <citation>Kim HJ, Lee JG, Kang JW, Cho HJ, Kim HS, Byeon HK, Yoon JH. Effects of a low concentration hypochlorous Acid nasal irrigation solution on bacteria, fungi, and virus. Laryngoscope. 2008 Oct;118(10):1862-7. doi: 10.1097/MLG.0b013e31817f4d34.</citation>
    <PMID>18677274</PMID>
  </reference>
  <reference>
    <citation>Robson MC, Payne WG, Ko F, Mentis M, Donati G, Shafii SM, Culverhouse S, Wang L, Khosrovi B, Najafi R, Cooper DM, Bassiri M. Hypochlorous Acid as a Potential Wound Care Agent: Part II. Stabilized Hypochlorous Acid: Its Role in Decreasing Tissue Bacterial Bioburden and Overcoming the Inhibition of Infection on Wound Healing. J Burns Wounds. 2007 Apr 11;6:e6.</citation>
    <PMID>17492051</PMID>
  </reference>
  <reference>
    <citation>Debabov D, Noorbakhsh C, Wang L, et al. Avenova™ with Neutrox™ (pure 0.01% HOCl) compared with OTC product (0.02% HOCl). NovaBay Pharmaceuticals, Inc., Emeryville, California, USA.</citation>
  </reference>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>January 30, 2020</last_update_submitted>
  <last_update_submitted_qc>January 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Wendy Lee</investigator_full_name>
    <investigator_title>Associate Professor of Clinical Ophthalmology &amp; Dermatology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chlorhexidine</mesh_term>
    <mesh_term>Povidone-Iodine</mesh_term>
    <mesh_term>Povidone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Requests can be e-mailed to Dr. Wendy Lee: WLee@med.miami.edu</ipd_description>
  </patient_data>
  <!-- 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/NCT02990013
org study id: 20160881
nct id: NCT02990013
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
Aim 1: To determine in vivo capability of AvenovaTM against common cutaneous microbial biome
      on human skin

      Aim 2: To compare to povidone-iodine 5% solution, 4% chlorhexidine and isopropyl alcohol
      against AvenovaTM as a sterile skin agent
A total of approximately 30 eligible participants will be identified with clinically-acquired
      information by Dr. Wendy Lee, an oculoplastic surgeon and aesthetic treatment specialist at
      Bascom Palmer Eye Institute, during regular clinic visits.

      Part One: Patients will have their skin swabbed and then cultured for various skin flora
      agents. The petri dish will then be swabbed with Avenova to see what percent of skin flora
      microbe is killed.

      Part Two: Patients will have their skin divided into 4 quadrants. The area will be
      pre-swabbed to monitor microbe growth. Each of 4 quadrants will be cleansed for one minute
      with AvenovaTM , povidone-iodine 5% solution, 4% chlorhexidine and isopropyl alcohol, then
      swabbed to monitor for microbe growth.

      The swabs will be placed in thioglycollate broth to monitor for bacterial growth. If growth
      if observed in the thioglycollate, the samples will be cultured on blood agar plates and the
      bacterial specie(s) identified.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Compare the efficacy of Avenova to other standard of care cleansing agents: growth vs. no growth
time frame: 12 months
description: Growth or no growth of bacteria in the thioglycollate broth will be noted for the control and each quadrant after cleansing with the 4 agents listed above.
measure: Bacterial Identification
time frame: 12 months
description: Positive thioglycollate samples will be cultured on blood agar plates and the bacterial species then identified.
arm group label: Treatment arm
arm group type: Experimental
description: All patients will be in the treatment arm where they will be subject to skin testing with various cleansing agents: AvenovaTM , povidone-iodine 5% solution, 4% chlorhexidine and isopropyl alcohol
intervention type: Device
intervention name: Avenova
description: Subjects will all undergo the treatment arm where their skin will be cleansed with four different agents: AvenovaTM , povidone-iodine 5% solution, 4% chlorhexidine and isopropyl alcohol
arm group label: Treatment arm
other name: hypochlorous acid
intervention type: Drug
intervention name: Povidone-iodine 5% solution
description: Subjects will all undergo the treatment arm where their skin will be cleansed with four different agents: AvenovaTM , povidone-iodine 5% solution, 4% chlorhexidine and isopropyl alcohol
arm group label: Treatment arm
other name: Betadine
intervention type: Drug
intervention name: 4% chlorhexidine
description: Subjects will all undergo the treatment arm where their skin will be cleansed with four different agents: AvenovaTM , povidone-iodine 5% solution, 4% chlorhexidine and isopropyl alcohol
arm group label: Treatment arm
other name: No other names
intervention type: Drug
intervention name: Isopropyl alcohol
description: Subjects will all undergo the treatment arm where their skin will be cleansed with four different agents: AvenovaTM , povidone-iodine 5% solution, 4% chlorhexidine and isopropyl alcohol
arm group label: Treatment arm
other name: No other names
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Wendy Lee
role: Principal Investigator
affiliation: Bascom Palmer Eye Institute University of Miami, Miller School of Medicine
facility: 
country: United States
citation: Collins LK, Knackstedt TJ, Samie FH. Antiseptic use in Mohs and reconstructive surgery: an American College of Mohs Surgery member survey. Dermatol Surg. 2015 Jan;41(1):164-6. doi: 10.1097/DSS.0000000000000202. No abstract available.
PMID: 25521104
citation: Steinsapir KD, Woodward JA. Chlorhexidine Keratitis: Safety of Chlorhexidine as a Facial Antiseptic. Dermatol Surg. 2017 Jan;43(1):1-6. doi: 10.1097/DSS.0000000000000822.
PMID: 27399954
citation: Kim HJ, Lee JG, Kang JW, Cho HJ, Kim HS, Byeon HK, Yoon JH. Effects of a low concentration hypochlorous Acid nasal irrigation solution on bacteria, fungi, and virus. Laryngoscope. 2008 Oct;118(10):1862-7. doi: 10.1097/MLG.0b013e31817f4d34.
PMID: 18677274
citation: Robson MC, Payne WG, Ko F, Mentis M, Donati G, Shafii SM, Culverhouse S, Wang L, Khosrovi B, Najafi R, Cooper DM, Bassiri M. Hypochlorous Acid as a Potential Wound Care Agent: Part II. Stabilized Hypochlorous Acid: Its Role in Decreasing Tissue Bacterial Bioburden and Overcoming the Inhibition of Infection on Wound Healing. J Burns Wounds. 2007 Apr 11;6:e6.
PMID: 17492051
citation: Debabov D, Noorbakhsh C, Wang L, et al. Avenova™ with Neutrox™ (pure 0.01% HOCl) compared with OTC product (0.02% HOCl). NovaBay Pharmaceuticals, Inc., Emeryville, California, USA.
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Wendy Lee
investigator title: Associate Professor of Clinical Ophthalmology & Dermatology
mesh term: Infertility
mesh term: Chlorhexidine
mesh term: Povidone-Iodine
mesh term: Povidone
sharing ipd: No
ipd description: Requests can be e-mailed to Dr. Wendy Lee: WLee@med.miami.edu