<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/NCT03282994</url>
  </required_header>
  <id_info>
    <org_study_id>R2-17-003</org_study_id>
    <nct_id>NCT03282994</nct_id>
  </id_info>
  <brief_title>Dermal Cooling System for Cryotherapy of Common Skin Conditions</brief_title>
  <official_title>Evaluation of the Dermal Cooling System for Cryotherapy of Common Skin Conditions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>R2 Dermatology</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>R2 Dermatology</source>
  <oversight_info>
    <has_dmc>No</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>
      Prospective, non-randomized, open-label study to evaluate the dermal cooling system for&#xD;
      cryotherapy of common skin conditions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to establish that controlled localized cooling with the Dermal&#xD;
      Cooling System will elicit an improvement in the cosmetic appearance of benign superficial&#xD;
      lesions associated with common skin conditions that are currently being treated with&#xD;
      cryosurgical methods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 19, 2017</start_date>
  <completion_date type="Actual">November 17, 2018</completion_date>
  <primary_completion_date type="Actual">November 17, 2018</primary_completion_date>
  <phase>N/A</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in appearance in the treatment area</measure>
    <time_frame>3-months</time_frame>
    <description>Improvement in appearance in the treated area at the 3-month follow-up visit, as determined by the Physician Global Assessment (PGA).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of procedure related adverse events</measure>
    <time_frame>less than 12 months</time_frame>
    <description>• Safety of the treatment as determined by the incidence of device- or procedure-related serious adverse events</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Skin Lesion</condition>
  <arm_group>
    <arm_group_label>Treatment with cryotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dermal Cooling System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dermal Cooling System</intervention_name>
    <description>Cryotherapy</description>
    <arm_group_label>Treatment with cryotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female subjects &gt; 18 years of age.&#xD;
&#xD;
          2. Subject has benign superficial lesion(s) associated with common skin conditions&#xD;
             amenable to cryosurgical treatment including, for example, psoriasis, acne, rosacea,&#xD;
             and sebaceous hyperplasia.&#xD;
&#xD;
          3. Subject is willing to have up to 40 test sites treated.&#xD;
&#xD;
          4. Subject has read and signed a written informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Physician prescribed procedures in the area of intended treatment in the previous 6&#xD;
             months (e.g., photodynamic therapy, intense pulsed light therapy, laser surgery).&#xD;
&#xD;
          2. Dermatological conditions (e.g. vitiligo, open wounds, infection, pre-cancerous or&#xD;
             malignant lesions) in the location of the treatment sites that would, in the&#xD;
             professional opinion of the investigator, potentially pose an increased risk to the&#xD;
             subject.&#xD;
&#xD;
          3. History of melanoma.&#xD;
&#xD;
          4. Known history of illness or adverse reaction to cold insult (e.g., cryoglobulinemia,&#xD;
             cold urticaria, paroxysmal cold hemoglobinuria, Reynaud's disease).&#xD;
&#xD;
          5. History of abnormal wound healing or abnormal scarring&#xD;
&#xD;
          6. Inability or unwillingness to comply with the study requirements.&#xD;
&#xD;
          7. Subject is pregnant or planning to become pregnant while enrolled in the study.&#xD;
&#xD;
          8. Subject is lactating.&#xD;
&#xD;
          9. Current enrollment in a clinical study of any other unapproved investigational drug or&#xD;
             device.&#xD;
&#xD;
         10. Any other condition or laboratory value that would, in the professional opinion of the&#xD;
             investigator, potentially affect response or participation in this clinical study, or&#xD;
             would pose an increased or unacceptable risk to the subject.&#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>Kristine Tatsutani, PhD</last_name>
    <role>Study Director</role>
    <affiliation>R2 Dermatology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clear Dermatology &amp; Aesthetics Center</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85255</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zel Skin and Laser Specialists</name>
      <address>
        <city>Edina</city>
        <state>Minnesota</state>
        <zip>55424</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology, Laser and Vein Specialists of the Carolinas</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>August 28, 2023</last_update_submitted>
  <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2023</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>Skin Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03282994
org study id: R2-17-003
nct id: NCT03282994
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
Prospective, non-randomized, open-label study to evaluate the dermal cooling system for
      cryotherapy of common skin conditions.
The purpose of this study is to establish that controlled localized cooling with the Dermal
      Cooling System will elicit an improvement in the cosmetic appearance of benign superficial
      lesions associated with common skin conditions that are currently being treated with
      cryosurgical methods.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Improvement in appearance in the treatment area
time frame: 3-months
description: Improvement in appearance in the treated area at the 3-month follow-up visit, as determined by the Physician Global Assessment (PGA).
measure: Incidence of procedure related adverse events
time frame: less than 12 months
description: • Safety of the treatment as determined by the incidence of device- or procedure-related serious adverse events
arm group label: Treatment with cryotherapy
arm group type: Experimental
description: Dermal Cooling System
intervention type: Device
intervention name: Dermal Cooling System
description: Cryotherapy
arm group label: Treatment with cryotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kristine Tatsutani, PhD
role: Study Director
affiliation: R2 Dermatology
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Skin Diseases
sharing ipd: No