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

Primary Purpose

Vitiligo

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RECELL® Autologous Cell Harvesting Device
Sponsored by
Avita Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitiligo focused on measuring focal vitiligo, segmental vitiligo, nonsegmental vitiligo, generalized vitiligo

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. The patient is a candidate for surgical intervention of a depigmented area, defined as a patient who has not satisfactorily responded to either: topical therapy or a minimum of 3 months of phototherapy. The patient has a depigmented area available for treatment that is: ≥90% depigmented, without any other dermatologic conditions (other than vitiligo), and excludes the lips, eyelids, plantar surface of feet, palmar surface of hands. The patient is 18 years of age or older. The patient agrees to remain on any current use of immunosuppressive therapy for the duration of his/her participation in the study (24 weeks). The patient is willing and able to comply with post-treatment at-home phototherapy and all follow-up study visits. The patient agrees to abstain from any other treatment of the study area for the duration of his/her participation in the study (24 weeks). The patient agrees to abstain from enrollment in any other interventional clinical trial for the duration of his/her participation in the study (24 weeks). In the opinion of the investigator, the patient must be able to: Understand the full nature and purpose of the study, including possible risks and benefits, Understand instructions and be able to comprehend and complete study questionnaires, and Provide voluntary written informed consent. - Exclusion Criteria: The patient is unable to undergo treatment area preparation. Patients who received RECELL treatment for vitiligo in Protocol No. CTP008 or CTP009. Patients with: depigmented lips and fingertips (lip-tip vitiligo), or depigmented areas over >30% of their body surface area. Patients with recent history (within previous 12 months) of: Koebnerization, confetti-like, or trichrome lesions. Patients with a history of keloid formation. The patient has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives. 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. 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 -

Sites / Locations

  • Affiliated DermatologyRecruiting
  • University of California, IrvineRecruiting
  • University of Southern California
  • University of California, Davis
  • West Dermatology Research CenterRecruiting
  • California Dermatology Institute
  • Clarity DermatologyRecruiting
  • Skin Care Research, LLCRecruiting
  • University Medical Center
  • Dermatologic Surgery Center of WashingtonRecruiting
  • University Of MassachusettsRecruiting
  • Hamzavi DermatologyRecruiting
  • Henry Ford Health
  • Grekin Skin Institute
  • Mount Sinai
  • Dermatology, Laser and Vein Specialists of the CarolinasRecruiting
  • University of Texas at Austin

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Study Treatment

Arm Description

Skin cell suspension prepared using the RECELL System will be applied to a prepared treatment area, followed by at-home NB-UVB phototherapy.

Outcomes

Primary Outcome Measures

Repigmentation 26-50%, 51-79%, 80-99%, and 100%)
Central Review Committee categorization of index area repigmentation

Secondary Outcome Measures

Full Information

First Posted
July 24, 2023
Last Updated
October 18, 2023
Sponsor
Avita Medical
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1. Study Identification

Unique Protocol Identification Number
NCT05971381
Brief Title
Repigmentation of Stable Vitiligo Lesions Using Spray-On Skin™ Cells
Acronym
TONE
Official Title
The TONE Study: A Prospective Post-Market Clinical Study Investigating Repigmentation of Stable Vitiligo Lesions Using Spray-On Skin™ Cells
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 14, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avita Medical

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo
Keywords
focal vitiligo, segmental vitiligo, nonsegmental vitiligo, generalized vitiligo

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study Treatment
Arm Type
Other
Arm 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(s)
RECELL® Autologous Cell Harvesting Device
Other Intervention Name(s)
Spray-On SkinTM Cells
Intervention 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.
Primary Outcome Measure Information:
Title
Repigmentation 26-50%, 51-79%, 80-99%, and 100%)
Description
Central Review Committee categorization of index area repigmentation
Time Frame
24 weeks post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. The patient is a candidate for surgical intervention of a depigmented area, defined as a patient who has not satisfactorily responded to either: topical therapy or a minimum of 3 months of phototherapy. The patient has a depigmented area available for treatment that is: ≥90% depigmented, without any other dermatologic conditions (other than vitiligo), and excludes the lips, eyelids, plantar surface of feet, palmar surface of hands. The patient is 18 years of age or older. The patient agrees to remain on any current use of immunosuppressive therapy for the duration of his/her participation in the study (24 weeks). The patient is willing and able to comply with post-treatment at-home phototherapy and all follow-up study visits. The patient agrees to abstain from any other treatment of the study area for the duration of his/her participation in the study (24 weeks). The patient agrees to abstain from enrollment in any other interventional clinical trial for the duration of his/her participation in the study (24 weeks). In the opinion of the investigator, the patient must be able to: Understand the full nature and purpose of the study, including possible risks and benefits, Understand instructions and be able to comprehend and complete study questionnaires, and Provide voluntary written informed consent. - Exclusion Criteria: The patient is unable to undergo treatment area preparation. Patients who received RECELL treatment for vitiligo in Protocol No. CTP008 or CTP009. Patients with: depigmented lips and fingertips (lip-tip vitiligo), or depigmented areas over >30% of their body surface area. Patients with recent history (within previous 12 months) of: Koebnerization, confetti-like, or trichrome lesions. Patients with a history of keloid formation. The patient has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives. 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. 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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Kirshner
Phone
833-462-8482
Email
ekirshner@avitamedical.com
Facility Information:
Facility Name
Affiliated Dermatology
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85225
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsey Wagner
Email
l.wagner@prgresearch.com
First Name & Middle Initial & Last Name & Degree
Karan Lal, DO
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcos Hurtado
Email
marcosh3@hs.uci.edu
First Name & Middle Initial & Last Name & Degree
Anand Ganesan, MD
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolina Mora Hurtado
Email
amora@wisc.edu
First Name & Middle Initial & Last Name & Degree
Nada Elbuluk, MD
Facility Name
University of California, Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Robb
Email
jmrobb@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Victor Huang, MD
Facility Name
West Dermatology Research Center
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sereno Cho
Email
scho@clderm.com
First Name & Middle Initial & Last Name & Degree
Raheel Zubair, MD
Facility Name
California Dermatology Institute
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91320
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shawn Ahoubim
Email
clinicaltrials@calderm.net
First Name & Middle Initial & Last Name & Degree
Navid Ezra, MD
Facility Name
Clarity Dermatology
City
Castle Rock
State/Province
Colorado
ZIP/Postal Code
80109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mallory Hull
Email
m.hull@prgresearch.com
First Name & Middle Initial & Last Name & Degree
Daniel Jensen, MD
Facility Name
Skin Care Research, LLC
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lori Aptekar
Email
laptekar@dermcaremgt.com
First Name & Middle Initial & Last Name & Degree
Eduardo Weiss, MD
Facility Name
University Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70122
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shana Lennard, RN
Email
slenna@lsuhsc.edu
First Name & Middle Initial & Last Name & Degree
Herb Phelan, MD
Facility Name
Dermatologic Surgery Center of Washington
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marlyn Antwan
Email
marlyn.antwan@mohs-md.com
First Name & Middle Initial & Last Name & Degree
Maral Skelsey, MD
Facility Name
University Of Massachusetts
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Celia Hartigan, RN
Email
Celia.Hartigan@umassmed.edu
First Name & Middle Initial & Last Name & Degree
Bassel Mahmoud, MD
Facility Name
Hamzavi Dermatology
City
Canton
State/Province
Michigan
ZIP/Postal Code
48187
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee Campbell, RN
Email
lcampbell@hamzavi.com
First Name & Middle Initial & Last Name & Degree
Iltefat Hamzavi, MD
Facility Name
Henry Ford Health
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Creasor, RN
Email
jcreaso2@hfhs.org
First Name & Middle Initial & Last Name & Degree
Richard Huggins, MD
Facility Name
Grekin Skin Institute
City
Warren
State/Province
Michigan
ZIP/Postal Code
48088
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia Attala
Phone
586-759-5525
Email
claudia.attala@adcsclinics.com
First Name & Middle Initial & Last Name & Degree
Steven Grekin, DO
Facility Name
Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10028
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingrid Sanabria
Email
Ingrid.Sanabria@mountsinai.org
First Name & Middle Initial & Last Name & Degree
Nanette Silverberg, MD
Facility Name
Dermatology, Laser and Vein Specialists of the Carolinas
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Razia Ludin
Email
razial@carolinaskin.com
First Name & Middle Initial & Last Name & Degree
Gilly Munavalli, MD
Facility Name
University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kate Sebastian, RN
Email
kate.sebastian@austin.utexas.edu
First Name & Middle Initial & Last Name & Degree
Amar Ahmed, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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