<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/NCT03243981</url>
  </required_header>
  <id_info>
    <org_study_id>IRB 37776</org_study_id>
    <nct_id>NCT03243981</nct_id>
  </id_info>
  <brief_title>Infrared and Broadband Light for Skin Aging</brief_title>
  <official_title>Augmentation of Skin Aging Reversal By Broadband Light With Skin Tightening Properties Via Gene Expression Analysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sciton</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Stanford University</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this exploratory study, we hope to learn if treatment of broadband light with infrared&#xD;
      light can alter the molecular pathways associated with aging. Secondary exploratory objective&#xD;
      is to see if there are any visible effects of this light treatment on human skin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Studies in model organisms suggest that aged cells can be functionally rejuvenated, but&#xD;
      whether this concept applies to human skin is unclear. Recently, we applied 3'-end sequencing&#xD;
      for expression quantification (&quot;3-seq&quot;) to discover the gene expression program associated&#xD;
      with human photoaging and intrinsic skin aging (collectively termed &quot;skin aging&quot;), and the&#xD;
      impact of broadband light (BBL) treatment. We found significant changes in 2,265 coding and&#xD;
      noncoding RNAs, of which 1,293 that became &quot;rejuvenated&quot; after BBL treatment, whereby they&#xD;
      became more similar to their expression level in youthful skin. Rejuvenated genes (RGs)&#xD;
      included several known key regulators of organismal longevity and their proximal long&#xD;
      noncoding RNAs. Hence, BBL treatment can restore gene expression pattern of photo-aged and&#xD;
      intrinsically aged human skin to resemble young skin.&#xD;
&#xD;
      However, the duration of these effects and the potential to augment these effects through&#xD;
      increases in particular wavelengths of light have not been explored. The Sciton SkinTyte&#xD;
      (800-1800nm) is the ideal technology to examine these questions, since this device has been&#xD;
      used in the clinical setting to reduce cheek and submental laxity (Gold, 2010). It&#xD;
      incorporates the broadband light technology with an emphasis on 590 nm filter to achieve&#xD;
      these clinical results.&#xD;
&#xD;
      This study will be conducted in accord with Declaration of Helsinki principles. After&#xD;
      Institutional Review Board approval and informed consent is obtained, six female participants&#xD;
      over the age of 55 years will undergo BBLST treatments to the left forearm. Inclusion&#xD;
      criteria included Fitzpatrick skin type II or III, and a global assessment of forearm skin&#xD;
      aging consistent with moderate or severe forearm skin aging (modified validated instrument&#xD;
      from McKenzie et al., 2011) for treated participants. Treatments will be performed on the&#xD;
      Sciton Joule Platform using BBL in Skintyte mode with 590ST filter. On a separate part of the&#xD;
      arm that is clearly marked, Skintyte alone will be applied. Untreated areas will also be&#xD;
      marked. All markings will be photographed. The same investigator will perform the treatments&#xD;
      at 4-week intervals for a total of 3 treatments. At each treatment session, two or more&#xD;
      passes were performed. Four weeks after the third BBL treatment, 4 mm skin biopsies will&#xD;
      performed by Keys punch technique from the BBLST treated, ST treated and adjacent untreated&#xD;
      skin. These specimens will be bisected and placed into either RNAlater (Ambion Cat# AM7022)&#xD;
      or formalin solution for with H&amp;E, von Giesen or PAS staining.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 20, 2016</start_date>
  <completion_date type="Actual">June 20, 2017</completion_date>
  <primary_completion_date type="Actual">June 20, 2017</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>
    <intervention_model_description>Application of Skintyte and/or broadband light to skin</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Genes With Significant Change in Gene Transcription</measure>
    <time_frame>16 weeks</time_frame>
    <description>The endpoint consisted of clinical inspection of biopsies of untreated skin and skin after three treatments. Genes were considered altered if a statistically significant change in transcription of an individual gene was observed between the treated and untreated skin (significance was set at p&lt;0.01, adjusted for false discovery rate). The values in the table represent the total number of recorded genes with significant change.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fine Wrinkling Score as a Measure of Skin Rejuvenation</measure>
    <time_frame>Baseline, day 84</time_frame>
    <description>Wrinkling was assessed on a 10 point Likert scale (range 1-10); higher scores correspond to more wrinkling.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Coarse Wrinkling Score as a Measure of Skin Rejuvenation</measure>
    <time_frame>Baseline, day 84</time_frame>
    <description>Wrinkling was assessed on a 10 point Likert scale (range 1-10); higher scores correspond to more wrinkling.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Sagging Score as a Measure of Skin Rejuvenation</measure>
    <time_frame>Baseline, day 84</time_frame>
    <description>Sagging was assessed on a 10 point Likert scale (range 1-10); higher scores correspond to more sagging.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Physician Global Assessment as a Measure of Skin Rejuvenation</measure>
    <time_frame>Baseline, day 84</time_frame>
    <description>Physician global assessment was assessed on a 10 point Likert scale (range 1-10); higher scores correspond to more severe skin aging.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Cutometry as a Measure of Skin Rejuvenation</measure>
    <time_frame>Baseline, day 84</time_frame>
    <description>Elasticity of skin assessment with cutometric probe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Transepidermal Water Loss as a Measure of Skin Rejuvenation</measure>
    <time_frame>Baseline, day 84</time_frame>
    <description>Transepidermal water loss assessment with VapoMeter.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Aging</condition>
  <arm_group>
    <arm_group_label>Open label study-- single arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients will receive Skintyte treatment as well as Skintyte plus broadband light</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sciton SkinTyte (800-1800 nm) with Broadband Light Technology</intervention_name>
    <description>This device has been used in the clinical setting to reduce cheek and submental laxity. SkinTyte delivers sequentially pulsed light (800-1200 nm, with a filter enabling focus on 590 nm) and broadband light (which can be turned on or off).</description>
    <arm_group_label>Open label study-- single arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Female 2. Age 55 years or older (total 6) 3. Fitzpatrick skin type 2-3 4.&#xD;
             Photo-aging at least moderate on the extensor forearms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Unable to understand and sign informed consent form 2. Unable to comply with study&#xD;
             procedures 3. Pregnant or lactating 4. Prior treatment to forearms including topical&#xD;
             retinoid, laser treatment, photodynamic treatment, prescription topical agents x 1&#xD;
             month 5. Active skin conditions that precluding treatment including zoster, blistering&#xD;
             skin disease, psoriasis, atopic dermatitis, abnormal scarring, skin cancer in the area&#xD;
             of study treatment 6. Currently on hormone based therapy (both systemic and topical)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Redwood City</city>
        <state>California</state>
        <zip>94063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>July 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <results_first_submitted>August 15, 2019</results_first_submitted>
  <results_first_submitted_qc>September 11, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 1, 2019</results_first_posted>
  <last_update_submitted>September 11, 2019</last_update_submitted>
  <last_update_submitted_qc>September 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Anne Chang</investigator_full_name>
    <investigator_title>Associate Professor of Dermatology</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 16, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/81/NCT03243981/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Skintyte</title>
          <description>All patients will receive Skintyte treatment as well as Skintyte plus broadband light using the Sciton SkinTyte device.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Skintyte</title>
          <description>All patients will receive Skintyte treatment as well as Skintyte plus broadband light using the Sciton SkinTyte device.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="5"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.6" spread="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Genes With Significant Change in Gene Transcription</title>
        <description>The endpoint consisted of clinical inspection of biopsies of untreated skin and skin after three treatments. Genes were considered altered if a statistically significant change in transcription of an individual gene was observed between the treated and untreated skin (significance was set at p&lt;0.01, adjusted for false discovery rate). The values in the table represent the total number of recorded genes with significant change.</description>
        <time_frame>16 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>BBL + SPL590 vs Untreated</title>
            <description>Biopsies were collected from the BBL + SPL590-treated arm (proximal forearm) and the untreated arm (mid-forearm)&#xD;
BBL = broadband light; SPL = sequentially pulsed light</description>
          </group>
          <group group_id="O2">
            <title>SPL800 (SkinTite 2) vs Untreated</title>
            <description>Biopsies were collected fro the SPL800-treated arm (distal forearm) vs untreated arm (mid-forearm)&#xD;
SPL800 = SkinTite 2</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Genes With Significant Change in Gene Transcription</title>
          <description>The endpoint consisted of clinical inspection of biopsies of untreated skin and skin after three treatments. Genes were considered altered if a statistically significant change in transcription of an individual gene was observed between the treated and untreated skin (significance was set at p&lt;0.01, adjusted for false discovery rate). The values in the table represent the total number of recorded genes with significant change.</description>
          <units>genes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="188"/>
                    <measurement group_id="O2" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Fine Wrinkling Score as a Measure of Skin Rejuvenation</title>
        <description>Wrinkling was assessed on a 10 point Likert scale (range 1-10); higher scores correspond to more wrinkling.</description>
        <time_frame>Baseline, day 84</time_frame>
        <population>Participants that had assessments at baseline and day 84 are included in the analysis</population>
        <group_list>
          <group group_id="O1">
            <title>BBL + SPL590</title>
            <description>Treatment on proximal forearm</description>
          </group>
          <group group_id="O2">
            <title>SPL800</title>
            <description>Treatment on distal forearm</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Fine Wrinkling Score as a Measure of Skin Rejuvenation</title>
          <description>Wrinkling was assessed on a 10 point Likert scale (range 1-10); higher scores correspond to more wrinkling.</description>
          <population>Participants that had assessments at baseline and day 84 are included in the analysis</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.8" spread="1.89"/>
                    <measurement group_id="O2" value="7.5" spread="3.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 84</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" spread="3.46"/>
                    <measurement group_id="O2" value="5.3" spread="3.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Coarse Wrinkling Score as a Measure of Skin Rejuvenation</title>
        <description>Wrinkling was assessed on a 10 point Likert scale (range 1-10); higher scores correspond to more wrinkling.</description>
        <time_frame>Baseline, day 84</time_frame>
        <population>Participants that had assessments at baseline and day 84 are included in the analysis</population>
        <group_list>
          <group group_id="O1">
            <title>BBL + SPL590</title>
            <description>Treatment on proximal forearm</description>
          </group>
          <group group_id="O2">
            <title>SPL800</title>
            <description>Treatment on distal forearm</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Coarse Wrinkling Score as a Measure of Skin Rejuvenation</title>
          <description>Wrinkling was assessed on a 10 point Likert scale (range 1-10); higher scores correspond to more wrinkling.</description>
          <population>Participants that had assessments at baseline and day 84 are included in the analysis</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" spread="3.65"/>
                    <measurement group_id="O2" value="6.0" spread="1.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 84</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="2.63"/>
                    <measurement group_id="O2" value="2.5" spread="1.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Sagging Score as a Measure of Skin Rejuvenation</title>
        <description>Sagging was assessed on a 10 point Likert scale (range 1-10); higher scores correspond to more sagging.</description>
        <time_frame>Baseline, day 84</time_frame>
        <population>Participants that had assessments at baseline and day 84 are included in the analysis</population>
        <group_list>
          <group group_id="O1">
            <title>BBL + SPL590</title>
            <description>Treatment on proximal forearm</description>
          </group>
          <group group_id="O2">
            <title>SPL800</title>
            <description>Treatment on distal forearm</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Sagging Score as a Measure of Skin Rejuvenation</title>
          <description>Sagging was assessed on a 10 point Likert scale (range 1-10); higher scores correspond to more sagging.</description>
          <population>Participants that had assessments at baseline and day 84 are included in the analysis</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.0" spread="1.63"/>
                    <measurement group_id="O2" value="7.5" spread="1.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 84</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" spread="1.73"/>
                    <measurement group_id="O2" value="4.3" spread="2.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Physician Global Assessment as a Measure of Skin Rejuvenation</title>
        <description>Physician global assessment was assessed on a 10 point Likert scale (range 1-10); higher scores correspond to more severe skin aging.</description>
        <time_frame>Baseline, day 84</time_frame>
        <population>Participants that had assessments at baseline and day 84 are included in the analysis</population>
        <group_list>
          <group group_id="O1">
            <title>BBL + SPL590</title>
            <description>Treatment on proximal forearm</description>
          </group>
          <group group_id="O2">
            <title>SPL800</title>
            <description>Treatment on distal forearm</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Physician Global Assessment as a Measure of Skin Rejuvenation</title>
          <description>Physician global assessment was assessed on a 10 point Likert scale (range 1-10); higher scores correspond to more severe skin aging.</description>
          <population>Participants that had assessments at baseline and day 84 are included in the analysis</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3" spread="0.96"/>
                    <measurement group_id="O2" value="8.3" spread="1.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 84</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" spread="2.08"/>
                    <measurement group_id="O2" value="6.0" spread="1.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Cutometry as a Measure of Skin Rejuvenation</title>
        <description>Elasticity of skin assessment with cutometric probe.</description>
        <time_frame>Baseline, day 84</time_frame>
        <population>Data were not collected for this outcome</population>
        <group_list>
          <group group_id="O1">
            <title>BBL + SPL590</title>
            <description>Treatment on proximal forearm</description>
          </group>
          <group group_id="O2">
            <title>SPL800</title>
            <description>Treatment on distal forearm</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Cutometry as a Measure of Skin Rejuvenation</title>
          <description>Elasticity of skin assessment with cutometric probe.</description>
          <population>Data were not collected for this outcome</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Transepidermal Water Loss as a Measure of Skin Rejuvenation</title>
        <description>Transepidermal water loss assessment with VapoMeter.</description>
        <time_frame>Baseline, day 84</time_frame>
        <population>Data were not collected for this outcome</population>
        <group_list>
          <group group_id="O1">
            <title>BBL + SPL590</title>
            <description>Treatment on proximal forearm</description>
          </group>
          <group group_id="O2">
            <title>SPL800</title>
            <description>Treatment on distal forearm</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Transepidermal Water Loss as a Measure of Skin Rejuvenation</title>
          <description>Transepidermal water loss assessment with VapoMeter.</description>
          <population>Data were not collected for this outcome</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 16 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>BBL + SPL590</title>
          <description>Treatment on proximal forearm</description>
        </group>
        <group group_id="E2">
          <title>SPL800</title>
          <description>Treatment on distal forearm</description>
        </group>
        <group group_id="E3">
          <title>Untreated</title>
          <description>Untreated area on mid-forearm</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The study did not meet its planned sample size.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Anne Lynn Chang, MD</name_or_title>
      <organization>Stanford University</organization>
      <phone>650-723-6316</phone>
      <email>alschang@stanford.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03243981
org study id: IRB 37776
nct id: NCT03243981
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
In this exploratory study, we hope to learn if treatment of broadband light with infrared
      light can alter the molecular pathways associated with aging. Secondary exploratory objective
      is to see if there are any visible effects of this light treatment on human skin.
Studies in model organisms suggest that aged cells can be functionally rejuvenated, but
      whether this concept applies to human skin is unclear. Recently, we applied 3'-end sequencing
      for expression quantification ("3-seq") to discover the gene expression program associated
      with human photoaging and intrinsic skin aging (collectively termed "skin aging"), and the
      impact of broadband light (BBL) treatment. We found significant changes in 2,265 coding and
      noncoding RNAs, of which 1,293 that became "rejuvenated" after BBL treatment, whereby they
      became more similar to their expression level in youthful skin. Rejuvenated genes (RGs)
      included several known key regulators of organismal longevity and their proximal long
      noncoding RNAs. Hence, BBL treatment can restore gene expression pattern of photo-aged and
      intrinsically aged human skin to resemble young skin.

      However, the duration of these effects and the potential to augment these effects through
      increases in particular wavelengths of light have not been explored. The Sciton SkinTyte
      (800-1800nm) is the ideal technology to examine these questions, since this device has been
      used in the clinical setting to reduce cheek and submental laxity (Gold, 2010). It
      incorporates the broadband light technology with an emphasis on 590 nm filter to achieve
      these clinical results.

      This study will be conducted in accord with Declaration of Helsinki principles. After
      Institutional Review Board approval and informed consent is obtained, six female participants
      over the age of 55 years will undergo BBLST treatments to the left forearm. Inclusion
      criteria included Fitzpatrick skin type II or III, and a global assessment of forearm skin
      aging consistent with moderate or severe forearm skin aging (modified validated instrument
      from McKenzie et al., 2011) for treated participants. Treatments will be performed on the
      Sciton Joule Platform using BBL in Skintyte mode with 590ST filter. On a separate part of the
      arm that is clearly marked, Skintyte alone will be applied. Untreated areas will also be
      marked. All markings will be photographed. The same investigator will perform the treatments
      at 4-week intervals for a total of 3 treatments. At each treatment session, two or more
      passes were performed. Four weeks after the third BBL treatment, 4 mm skin biopsies will
      performed by Keys punch technique from the BBLST treated, ST treated and adjacent untreated
      skin. These specimens will be bisected and placed into either RNAlater (Ambion Cat# AM7022)
      or formalin solution for with H&E, von Giesen or PAS staining.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Application of Skintyte and/or broadband light to skin
primary purpose: Other
masking: None (Open Label)
measure: Number of Genes With Significant Change in Gene Transcription
time frame: 16 weeks
description: The endpoint consisted of clinical inspection of biopsies of untreated skin and skin after three treatments. Genes were considered altered if a statistically significant change in transcription of an individual gene was observed between the treated and untreated skin (significance was set at p<0.01, adjusted for false discovery rate). The values in the table represent the total number of recorded genes with significant change.
measure: Change From Baseline in Fine Wrinkling Score as a Measure of Skin Rejuvenation
time frame: Baseline, day 84
description: Wrinkling was assessed on a 10 point Likert scale (range 1-10); higher scores correspond to more wrinkling.
measure: Change From Baseline in Coarse Wrinkling Score as a Measure of Skin Rejuvenation
time frame: Baseline, day 84
description: Wrinkling was assessed on a 10 point Likert scale (range 1-10); higher scores correspond to more wrinkling.
measure: Change From Baseline in Sagging Score as a Measure of Skin Rejuvenation
time frame: Baseline, day 84
description: Sagging was assessed on a 10 point Likert scale (range 1-10); higher scores correspond to more sagging.
measure: Change From Baseline in Physician Global Assessment as a Measure of Skin Rejuvenation
time frame: Baseline, day 84
description: Physician global assessment was assessed on a 10 point Likert scale (range 1-10); higher scores correspond to more severe skin aging.
measure: Change From Baseline in Cutometry as a Measure of Skin Rejuvenation
time frame: Baseline, day 84
description: Elasticity of skin assessment with cutometric probe.
measure: Change From Baseline in Transepidermal Water Loss as a Measure of Skin Rejuvenation
time frame: Baseline, day 84
description: Transepidermal water loss assessment with VapoMeter.
arm group label: Open label study-- single arm
arm group type: Experimental
description: All patients will receive Skintyte treatment as well as Skintyte plus broadband light
intervention type: Device
intervention name: Sciton SkinTyte (800-1800 nm) with Broadband Light Technology
description: This device has been used in the clinical setting to reduce cheek and submental laxity. SkinTyte delivers sequentially pulsed light (800-1200 nm, with a filter enabling focus on 590 nm) and broadband light (which can be turned on or off).
arm group label: Open label study-- single arm
criteria: 
gender: Female
minimum age: 55 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Anne Chang
investigator title: Associate Professor of Dermatology
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study did not meet its planned sample size.
point of contact: 