xml: <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/NCT05971381</url>
    </required_header>
    <id_info>
      <org_study_id>CTP010</org_study_id>
      <nct_id>NCT05971381</nct_id>
    </id_info>
    <brief_title>Repigmentation of Stable Vitiligo Lesions Using Spray-On Skin™ Cells</brief_title>
    <acronym>TONE</acronym>
    <official_title>The TONE Study: A Prospective Post-Market Clinical Study Investigating Repigmentation of Stable Vitiligo Lesions Using Spray-On Skin™ Cells</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Avita Medical</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Avita Medical</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>
        To evaluate repigmentation and quality of life after treatment of stable vitiligo lesions&#xD;
        using the RECELL Device.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Prospective, multicenter single-arm pre-/post interventional study to evaluate the clinical&#xD;
        performance of RECELL for repigmentation of stable depigmented lesions.Skin cell suspension&#xD;
        prepared using the RECELL System will be applied to a prepared treatment area, followed by&#xD;
        at-home NB-UVB phototherapy.&#xD;
  &#xD;
        Repigmentation of treatment areas will be determined via centralized image interpretation by&#xD;
        an expert dermatological panel (i.e., Central Review Committee, CRC).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 14, 2023</start_date>
    <completion_date type="Anticipated">July 2024</completion_date>
    <primary_completion_date type="Anticipated">June 2024</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>Repigmentation 26-50%, 51-79%, 80-99%, and 100%)</measure>
      <time_frame>24 weeks post-treatment</time_frame>
      <description>Central Review Committee categorization of index area repigmentation</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Vitiligo</condition>
    <arm_group>
      <arm_group_label>Study Treatment</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Skin cell suspension prepared using the RECELL System will be applied to a prepared treatment area, followed by at-home NB-UVB phototherapy.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>RECELL® Autologous Cell Harvesting Device</intervention_name>
      <description>The RECELL Device is for use at the patient's point-of-care for the safe and rapid preparation of Spray-On SkinTM Cells from a small sample of a patient's own skin.</description>
      <arm_group_label>Study Treatment</arm_group_label>
      <other_name>Spray-On SkinTM Cells</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Focal, segmental, or generalized (i.e., nonsegmental) stable vitiligo, defined as no&#xD;
               new depigmented areas nor any depigmented areas that have expanded in size within the&#xD;
               preceding 12 months.&#xD;
  &#xD;
            2. The patient is a candidate for surgical intervention of a depigmented area, defined as&#xD;
               a patient who has not satisfactorily responded to either:&#xD;
  &#xD;
                 1. topical therapy or&#xD;
  &#xD;
                 2. a minimum of 3 months of phototherapy.&#xD;
  &#xD;
            3. The patient has a depigmented area available for treatment that is:&#xD;
  &#xD;
                 1. ≥90% depigmented,&#xD;
  &#xD;
                 2. without any other dermatologic conditions (other than vitiligo), and&#xD;
  &#xD;
                 3. excludes the lips, eyelids, plantar surface of feet, palmar surface of hands.&#xD;
  &#xD;
            4. The patient is 18 years of age or older.&#xD;
  &#xD;
            5. The patient agrees to remain on any current use of immunosuppressive therapy for the&#xD;
               duration of his/her participation in the study (24 weeks).&#xD;
  &#xD;
            6. The patient is willing and able to comply with post-treatment at-home phototherapy and&#xD;
               all follow-up study visits.&#xD;
  &#xD;
            7. The patient agrees to abstain from any other treatment of the study area for the&#xD;
               duration of his/her participation in the study (24 weeks).&#xD;
  &#xD;
            8. The patient agrees to abstain from enrollment in any other interventional clinical&#xD;
               trial for the duration of his/her participation in the study (24 weeks).&#xD;
  &#xD;
            9. In the opinion of the investigator, the patient must be able to:&#xD;
  &#xD;
                 1. Understand the full nature and purpose of the study, including possible risks and&#xD;
                    benefits,&#xD;
  &#xD;
                 2. Understand instructions and be able to comprehend and complete study&#xD;
                    questionnaires, and&#xD;
  &#xD;
                 3. Provide voluntary written informed consent. -&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. The patient is unable to undergo treatment area preparation.&#xD;
  &#xD;
            2. Patients who received RECELL treatment for vitiligo in Protocol No. CTP008 or CTP009.&#xD;
  &#xD;
            3. Patients with:&#xD;
  &#xD;
                 1. depigmented lips and fingertips (lip-tip vitiligo), or&#xD;
  &#xD;
                 2. depigmented areas over &gt;30% of their body surface area.&#xD;
  &#xD;
            4. Patients with recent history (within previous 12 months) of:&#xD;
  &#xD;
                 1. Koebnerization,&#xD;
  &#xD;
                 2. confetti-like, or&#xD;
  &#xD;
                 3. trichrome lesions.&#xD;
  &#xD;
            5. Patients with a history of keloid formation.&#xD;
  &#xD;
            6. The patient has other concurrent conditions that in the opinion of the investigator&#xD;
               may compromise patient safety or study objectives.&#xD;
  &#xD;
            7. Current use of medications (e.g., anticoagulants such as heparin or warfarin) that in&#xD;
               the investigator's opinion may compromise patient safety or trial objectives.&#xD;
  &#xD;
            8. The patient has a known hypersensitivity to trypsin, compound sodium lactate for&#xD;
               irrigation solution (Hartmann's solution), povidone-iodine, chlorhexidine, and/or&#xD;
               lidocaine-containing anesthetics -&#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_contact>
      <last_name>Elizabeth Kirshner</last_name>
      <phone>833-462-8482</phone>
      <email>ekirshner@avitamedical.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of California, Irvine</name>
        <address>
          <city>Irvine</city>
          <state>California</state>
          <zip>92697</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Marocs Hurtado</last_name>
        <email>marcosh3@hs.uci.edu</email>
      </contact>
      <investigator>
        <last_name>Anand Ganesan, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University of Southern California</name>
        <address>
          <city>Los Angeles</city>
          <state>California</state>
          <zip>90017</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Carolina Mora Hurtado</last_name>
        <email>amora@wisc.edu</email>
      </contact>
      <investigator>
        <last_name>Nada Elbuluk, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University of California, Davis</name>
        <address>
          <city>Sacramento</city>
          <state>California</state>
          <zip>95816</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>John Robb</last_name>
        <email>jmrobb@ucdavis.edu</email>
      </contact>
      <investigator>
        <last_name>Victor Huang, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>West Dermatology Research Center</name>
        <address>
          <city>San Diego</city>
          <state>California</state>
          <zip>92121</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sereno Cho</last_name>
        <email>scho@clderm.com</email>
      </contact>
      <investigator>
        <last_name>Raheel Zubair, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Skin Care Research, LLC</name>
        <address>
          <city>Hollywood</city>
          <state>Florida</state>
          <zip>33021</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Lori Aptekar</last_name>
        <email>laptekar@dermcaremgt.com</email>
      </contact>
      <investigator>
        <last_name>Eduardo Weiss, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University Medical Center</name>
        <address>
          <city>New Orleans</city>
          <state>Louisiana</state>
          <zip>70122</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Shana Lennard, RN</last_name>
        <email>slenna@lsuhsc.edu</email>
      </contact>
      <investigator>
        <last_name>Jeffrey Carter, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Dermatologic Surgery Center of Washington</name>
        <address>
          <city>Chevy Chase</city>
          <state>Maryland</state>
          <zip>20815</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Marlyn Antwan</last_name>
        <email>marlyn.antwan@mohs-md.com</email>
      </contact>
      <investigator>
        <last_name>Maral Skelsey, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University Of Massachusetts</name>
        <address>
          <city>Worcester</city>
          <state>Massachusetts</state>
          <zip>01605</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Celia Hartigan, RN</last_name>
        <email>Celia.Hartigan@umassmed.edu</email>
      </contact>
      <investigator>
        <last_name>Bassel Mahmoud, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Hamzavi Dermatology</name>
        <address>
          <city>Canton</city>
          <state>Michigan</state>
          <zip>48187</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Lee Campbell, RN</last_name>
        <email>lcampbell@hamzavi.com</email>
      </contact>
      <investigator>
        <last_name>Iltefat Hamzavi, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Henry Ford Health</name>
        <address>
          <city>Detroit</city>
          <state>Michigan</state>
          <zip>48202</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Jennifer Creasor, RN</last_name>
        <email>jcreaso2@hfhs.org</email>
      </contact>
      <investigator>
        <last_name>Richard Huggins, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Grekin Skin Institute</name>
        <address>
          <city>Warren</city>
          <state>Michigan</state>
          <zip>48088</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Claudia Attala</last_name>
        <phone>586-759-5525</phone>
        <email>claudia.attala@adcsclinics.com</email>
      </contact>
      <investigator>
        <last_name>Steven Grekin, DO</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Mount Sinai</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10028</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Ingrid Sanabria</last_name>
        <email>Ingrid.Sanabria@mountsinai.org</email>
      </contact>
      <investigator>
        <last_name>Nanette Silverberg, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </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>
      <status>Recruiting</status>
      <contact>
        <last_name>Razia Ludin</last_name>
        <email>razial@carolinaskin.com</email>
      </contact>
      <investigator>
        <last_name>Gilly Munavalli, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University of Texas at Austin</name>
        <address>
          <city>Austin</city>
          <state>Texas</state>
          <zip>78712</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Kate Sebastian, RN</last_name>
        <email>kate.sebastian@austin.utexas.edu</email>
      </contact>
      <investigator>
        <last_name>Amar Ahmed, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>focal vitiligo</keyword>
    <keyword>segmental vitiligo</keyword>
    <keyword>nonsegmental vitiligo</keyword>
    <keyword>generalized vitiligo</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vitiligo</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05971381
  org study id: CTP010
  nct id: NCT05971381
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  To evaluate repigmentation and quality of life after treatment of stable vitiligo lesions
        using the RECELL Device.
  Prospective, multicenter single-arm pre-/post interventional study to evaluate the clinical
        performance of RECELL for repigmentation of stable depigmented lesions.Skin cell suspension
        prepared using the RECELL System will be applied to a prepared treatment area, followed by
        at-home NB-UVB phototherapy.
  
        Repigmentation of treatment areas will be determined via centralized image interpretation by
        an expert dermatological panel (i.e., Central Review Committee, CRC).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Repigmentation 26-50%, 51-79%, 80-99%, and 100%)
  time frame: 24 weeks post-treatment
  description: Central Review Committee categorization of index area repigmentation
  arm group label: Study Treatment
  arm group type: Other
  description: Skin cell suspension prepared using the RECELL System will be applied to a prepared treatment area, followed by at-home NB-UVB phototherapy.
  intervention type: Device
  intervention name: RECELL® Autologous Cell Harvesting Device
  description: The RECELL Device is for use at the patient's point-of-care for the safe and rapid preparation of Spray-On SkinTM Cells from a small sample of a patient's own skin.
  arm group label: Study Treatment
  other name: Spray-On SkinTM Cells
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Elizabeth Kirshner
  phone: 833-462-8482
  email: ekirshner@avitamedical.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Not yet recruiting
  contact: 
  investigator: 
  facility: 
  status: Not yet recruiting
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  status: Recruiting
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  status: Recruiting
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  status: Not yet recruiting
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  status: Recruiting
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  status: Not yet recruiting
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  status: Recruiting
  contact: 
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  status: Not yet recruiting
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  status: Not yet recruiting
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  status: Not yet recruiting
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  status: Recruiting
  contact: 
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  status: Not yet recruiting
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Vitiligo
  sharing ipd: No