Repigmentation of Stable Vitiligo Lesions Using Spray-On Skin™ Cells (TONE)

The TONE Study: A Prospective Post-Market Clinical Study Investigating Repigmentation of Stable Vitiligo Lesions Using Spray-On Skin™ Cells

To evaluate repigmentation and quality of life after treatment of stable vitiligo lesions using the RECELL Device.

Study Overview

• Status: Active, not recruiting
• Conditions: Vitiligo
• Intervention / Treatment: Device: RECELL® Autologous Cell Harvesting Device

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elizabeth Kirshner; Phone Number: 833-462-8482; Email: ekirshner@avitamedical.com

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85225
      • Affiliated Dermatology
  • California
    • Irvine, California, United States, 92697
      • University of California, Irvine
    • San Diego, California, United States, 92121
      • West Dermatology Research Center
    • Sunnyvale, California, United States, 94086
      • Sutter Health
    • Thousand Oaks, California, United States, 91320
      • California Dermatology Institute
  • Colorado
    • Castle Rock, Colorado, United States, 80109
      • Clarity Dermatology
  • Florida
    • Boynton Beach, Florida, United States, 33437
      • Siperstein Dermatology Group
    • Hollywood, Florida, United States, 33021
      • Skin Care Research, Llc
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Dermatologic Surgery Center of Washington
    • Hunt Valley, Maryland, United States, 21030
      • Maryland Laser, Skin & Vein Institute
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • University of Massachusetts
  • Michigan
    • Canton, Michigan, United States, 48187
      • Hamzavi Dermatology
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health
    • Warren, Michigan, United States, 48088
      • Grekin Skin Institute
  • New York
    • New York, New York, United States, 10012
      • The Dermatology Specialist
    • New York, New York, United States, 10028
      • Mount Sinai
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Dermatology, Laser and Vein Specialists of the Carolinas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Focal, segmental, or generalized (i.e., nonsegmental) stable vitiligo, defined as no new depigmented areas nor any depigmented areas that have expanded in size within the preceding 12 months.

2. The patient is a candidate for surgical intervention of a depigmented area, defined as a patient who has not satisfactorily responded to either:

   1. topical therapy or
   2. a minimum of 3 months of phototherapy.

3. The patient has a depigmented area available for treatment that is:

   1. ≥90% depigmented,
   2. without any other dermatologic conditions (other than vitiligo), and
   3. excludes the lips, eyelids, plantar surface of feet, palmar surface of hands.
4. The patient is 18 years of age or older.
5. The patient agrees to remain on any current use of immunosuppressive therapy for the duration of his/her participation in the study (52 weeks).
6. The patient is willing and able to comply with post-treatment at-home phototherapy and all follow-up study visits.
7. The patient agrees to abstain from any other treatment of the study area for the duration of his/her participation in the study (52 weeks).
8. The patient agrees to abstain from enrollment in any other interventional clinical trial for the duration of his/her participation in the study (52 weeks).

9. In the opinion of the investigator, the patient must be able to:

   1. Understand the full nature and purpose of the study, including possible risks and benefits,
   2. Understand instructions and be able to comprehend and complete study questionnaires, and
   3. Provide voluntary written informed consent. -

Exclusion Criteria:

1. The patient is unable to undergo treatment area preparation.
2. Patients who received RECELL treatment for vitiligo in Protocol No. CTP008 or CTP009.

3. Patients with:

   1. depigmented lips and fingertips (lip-tip vitiligo), or
   2. depigmented areas over >30% of their body surface area.

4. Patients with recent history (within previous 12 months) of:

   1. Koebnerization,
   2. confetti-like, or
   3. trichrome lesions.
5. Patients with a history of keloid formation.
6. The patient has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives.
7. Current use of medications (e.g., anticoagulants such as heparin or warfarin) that in the investigator's opinion may compromise patient safety or trial objectives.
8. The patient has a known hypersensitivity to trypsin, compound sodium lactate for irrigation solution (Hartmann's solution), povidone-iodine, chlorhexidine, and/or lidocaine-containing anesthetics -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Study Treatment; Skin cell suspension prepared using the RECELL System will be applied to a prepared treatment area, followed by at-home NB-UVB phototherapy.	Device: RECELL® Autologous Cell Harvesting Device; 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.; Other Names: Spray-On SkinTM Cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Repigmentation 0%,1-25%, 26-50%, 51-79%, 80-99%, and 100%)	Central Review Committee categorization of index area repigmentation	24 weeks post-treatment

Collaborators and Investigators

• Sponsor: Avita Medical

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: July 24, 2023
• First Submitted That Met QC Criteria: July 31, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Actual): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: segmental vitiligo; focal vitiligo; nonsegmental vitiligo; generalized vitiligo
• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation; Vitiligo
• Other Study ID Numbers: CTP010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No