<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/NCT04471896</url>
  </required_header>
  <id_info>
    <org_study_id>2521</org_study_id>
    <nct_id>NCT04471896</nct_id>
  </id_info>
  <brief_title>Joovvin' for Your Skin Health Study</brief_title>
  <official_title>Examining the Impact of Infrared Light Therapy Device on Cosmetic Skin Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ProofPilot</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Joovv</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>ProofPilot</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sixty day single arm trial examining self-report and remote dermatology assessment of&#xD;
      cosmetic skin health after daily 10-20 minute sessions with an infrared light therapy device&#xD;
      (the Joovv Mini)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Actual">February 1, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</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>Blinded Dermatology Assessment of Facial Skin Health</measure>
    <time_frame>60 day</time_frame>
    <description>Comparison over timepoints of physician assessment of facial features at rest and smile to the Glogau &amp; custom wrinkle selfie scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Self-Report Skin, Hair &amp; Nail Health and Satisfaction</measure>
    <time_frame>60 day</time_frame>
    <description>A custom self report survey on cosmetic skin health satisfaction</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Skin Inflammation</condition>
  <condition>Acne</condition>
  <condition>Skin Diseases</condition>
  <condition>Dermatological Non-Disease</condition>
  <condition>Skin Condition</condition>
  <condition>Eczema</condition>
  <arm_group>
    <arm_group_label>Treatment Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive an infrared therapy device for use at home for 60 days. Participants will use the device every day for 10-20 minutes during the intervention period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Joovv Mini</intervention_name>
    <description>Infrared light therapy uses certain wavelengths of light that are delivered to the face. This study will use the Joovv Mini.</description>
    <arm_group_label>Treatment Arm</arm_group_label>
    <other_name>Infrared light therapy device</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  willingness to use device for 60 days&#xD;
&#xD;
          -  willingness to place security deposit on device of $149.99&#xD;
&#xD;
          -  US resident with an address than can accept UPS deliveries&#xD;
&#xD;
          -  18 years old&#xD;
&#xD;
          -  no serious medical conditions&#xD;
&#xD;
          -  no medically treatable skin diseases&#xD;
&#xD;
          -  willingness to take a selfie with mobile phone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Retinoid use&#xD;
&#xD;
          -  prior use of light therapy within the past 6 months&#xD;
&#xD;
          -  pregnant or nursing&#xD;
&#xD;
          -  dietary supplements for skin, hair or nail health&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>ProofPilot (Virtual Study: https://p.proofpilot.com)</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 11, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>February 9, 2021</last_update_submitted>
  <last_update_submitted_qc>February 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2021</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>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04471896
org study id: 2521
nct id: NCT04471896
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Sixty day single arm trial examining self-report and remote dermatology assessment of
      cosmetic skin health after daily 10-20 minute sessions with an infrared light therapy device
      (the Joovv Mini)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Blinded Dermatology Assessment of Facial Skin Health
time frame: 60 day
description: Comparison over timepoints of physician assessment of facial features at rest and smile to the Glogau & custom wrinkle selfie scale
measure: Changes in Self-Report Skin, Hair & Nail Health and Satisfaction
time frame: 60 day
description: A custom self report survey on cosmetic skin health satisfaction
arm group label: Treatment Arm
arm group type: Experimental
description: Participants will receive an infrared therapy device for use at home for 60 days. Participants will use the device every day for 10-20 minutes during the intervention period.
intervention type: Device
intervention name: Joovv Mini
description: Infrared light therapy uses certain wavelengths of light that are delivered to the face. This study will use the Joovv Mini.
arm group label: Treatment Arm
other name: Infrared light therapy device
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Skin Diseases
mesh term: Dermatitis
mesh term: Inflammation
sharing ipd: Undecided