<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/NCT04493021</url>
  </required_header>
  <id_info>
    <org_study_id>R2-20-001</org_study_id>
    <nct_id>NCT04493021</nct_id>
  </id_info>
  <brief_title>Evaluation of the Dermal Cooling System for the Enhanced Treatment of Benign Pigmented Lesions and Common Skin Conditions</brief_title>
  <official_title>Evaluation of the Dermal Cooling System for the Enhanced Treatment of Benign Pigmented Lesions and 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the Dermal Cooling System for lightening of benign&#xD;
      pigmented lesions and to assess additional cosmetic benefits.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, non-randomized, open-label study to evaluate the effectiveness of the&#xD;
      Dermal Cooling system to reduce pigmentation in benign pigmented lesions and to determine if&#xD;
      additional cosmetic benefits are achieved.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 7, 2020</start_date>
  <completion_date type="Actual">May 31, 2022</completion_date>
  <primary_completion_date type="Actual">May 31, 2022</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 the appearance of the treated areas as assessed by Investigator assessment.</measure>
    <time_frame>2-Month Follow-up visit</time_frame>
    <description>Investigator assessment using Global Aesthetic Improvement Scale (GAIS); graded from &quot;4&quot; (very much improved&quot;) to &quot;0&quot; (worse).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety of the treatment</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Determined by incidence of device-or procedure-related adverse events</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">137</enrollment>
  <condition>Pigmentation</condition>
  <arm_group>
    <arm_group_label>Treatment with Dermal Cooling System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dermal Cooling System will be used in all eligible subjects.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dermal Cooling System</intervention_name>
    <description>Controlled localized cooling will be applied to benign pigmented lesions using the Dermal Cooling System</description>
    <arm_group_label>Treatment with Dermal Cooling System</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 one or more benign pigmented lesions (e.g., solar lentigines, freckles,&#xD;
             seborrheic keratosis), in an area suitable for treatment.&#xD;
&#xD;
          3. Subject is willing to have up to 40 treatment sites treated per treatment session&#xD;
             depending on the size and nature of the lesions identified.&#xD;
&#xD;
          4. Subject is willing to have digital photographs taken of the treatment area and agrees&#xD;
             to use of photographs for presentation, educational, or marketing purposes.&#xD;
&#xD;
          5. Subject is willing to cover treated area or have very limited sun exposure and use an&#xD;
             approved sunscreen of SPF 50 or higher on the treated area for the duration of the&#xD;
             study, including the follow-up period, if requested.&#xD;
&#xD;
          6. Subject has read and signed a written informed consent form.&#xD;
&#xD;
          7. Subject is willing to comply with adjuvant topical regimen, as applicable. -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Physician prescribed medical or surgical treatment, or use of over-the-counter&#xD;
             products to alter skin color, in the area of intended treatment in the previous 6&#xD;
             months (e.g., hydroquinone, corticosteroids, laser surgery)&#xD;
&#xD;
          2. Use of products containing glycolic acids, retinol, salicylic acid within the previous&#xD;
             2 weeks&#xD;
&#xD;
          3. Use of Accutane within the previous 6 months&#xD;
&#xD;
          4. Artificial tanning in the area of intended treatment within 1 month (e.g., spray,&#xD;
             lotion, tanning bed) or intention to use artificial tanning within the follow-up&#xD;
             period&#xD;
&#xD;
          5. Scars or tattoos in the location of the treatment sites&#xD;
&#xD;
          6. History of melasma, vitiligo, eczema, or psoriasis in the area of treatment&#xD;
&#xD;
          7. History of melanoma&#xD;
&#xD;
          8. Subject is pregnant or intending to become pregnant during the study period&#xD;
&#xD;
          9. Subject is lactating or has been lactating in the past 6 months&#xD;
&#xD;
         10. Known history of illness or adverse reaction to cold insult (e.g., cryoglobulinemia,&#xD;
             cold urticaria, paroxysmal cold hemoglobinuria, Reynaud's disease.&#xD;
&#xD;
         11. History of abnormal wound healing or abnormal scarring&#xD;
&#xD;
         12. Inability or unwillingness to comply with the study requirements.&#xD;
&#xD;
         13. Current enrollment in a clinical study of any other unapproved investigational drug or&#xD;
             device.&#xD;
&#xD;
         14. 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 unacceptable risk to the subject.&#xD;
&#xD;
             -&#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>Andre Bonnett, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sculptology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sculptology</name>
      <address>
        <city>Pleasanton</city>
        <state>California</state>
        <zip>94566</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>July 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</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>
  <!-- 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/NCT04493021
org study id: R2-20-001
nct id: NCT04493021
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this study is to evaluate the Dermal Cooling System for lightening of benign
      pigmented lesions and to assess additional cosmetic benefits.
This is a prospective, non-randomized, open-label study to evaluate the effectiveness of the
      Dermal Cooling system to reduce pigmentation in benign pigmented lesions and to determine if
      additional cosmetic benefits are achieved.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Improvement in the appearance of the treated areas as assessed by Investigator assessment.
time frame: 2-Month Follow-up visit
description: Investigator assessment using Global Aesthetic Improvement Scale (GAIS); graded from "4" (very much improved") to "0" (worse).
measure: Safety of the treatment
time frame: Up to 12 months
description: Determined by incidence of device-or procedure-related adverse events
arm group label: Treatment with Dermal Cooling System
arm group type: Experimental
description: Dermal Cooling System will be used in all eligible subjects.
intervention type: Device
intervention name: Dermal Cooling System
description: Controlled localized cooling will be applied to benign pigmented lesions using the Dermal Cooling System
arm group label: Treatment with Dermal Cooling System
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Andre Bonnett, MD
role: Principal Investigator
affiliation: Sculptology
facility: 
country: United States
responsible party type: Sponsor
mesh term: Skin Diseases