VitiligoTONENCT05971381
Repigmentation of Stable Vitiligo Lesions Using Spray-On Skin™ Cells
A study testing RECELL® Autologous Cell Harvesting Device in people with Vitiligo, run by Avita Medical at 17 sites in United States.
Trial summary
To evaluate repigmentation and quality of life after treatment of stable vitiligo lesions using the RECELL Device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitiligo
- What is being tested?
- RECELL® Autologous Cell Harvesting Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 17 sitesUnited States
- Study dates
- 14 Aug 2023to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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 (52 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 (52 weeks).
- 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).
- 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. -
Who cannot join
- 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:
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- 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 -
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Siperstein Dermatology Group
Boynton Beach, Florida, 33437
Hamzavi Dermatology
Canton, Michigan, 48187
Clarity Dermatology
Castle Rock, Colorado, 80109
Dermatology, Laser and Vein Specialists of the Carolinas
Charlotte, North Carolina, 28207
Dermatologic Surgery Center of Washington
Chevy Chase, Maryland, 20815
Henry Ford Health
Detroit, Michigan, 48202
Skin Care Research, LLC
Hollywood, Florida, 33021
Maryland Laser, Skin & Vein Institute
Hunt Valley, Maryland, 21030
University of California, Irvine
Irvine, California, 92697
The Dermatology Specialist
New York, New York, 10012
Mount Sinai
New York, New York, 10028
West Dermatology Research Center
San Diego, California, 92121
Affiliated Dermatology
Scottsdale, Arizona, 85225
Sutter Health
Sunnyvale, California, 94086
California Dermatology Institute
Thousand Oaks, California, 91320
Grekin Skin Institute
Warren, Michigan, 48088
University Of Massachusetts
Worcester, Massachusetts, 01605
About this study
Official title: 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.
Read the 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).
- Conditions
- Vitiligo
- Being tested
- RECELL® Autologous Cell Harvesting Device
- Keywords
- focal vitiligo, segmental vitiligo, nonsegmental vitiligo, generalized vitiligo
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RECELL® Autologous Cell Harvesting DeviceDevice
Also called Spray-On SkinTM Cells
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.
| Study group | Role | What they receive |
|---|---|---|
| Study Treatment | Other | Skin cell suspension prepared using the RECELL System will be applied to a prepared treatment area, followed by at-home NB-UVB phototherapy. Receives: Device: RECELL® Autologous Cell Harvesting Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repigmentation 0%,1-25%, 26-50%, 51-79%, 80-99%, and 100%)
Central Review Committee categorization of index area repigmentation
Measured: 24 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start14 Aug 2023
- Primary completion30 Jul 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avita Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971381
- Sponsor's protocol ID
- CTP010
- Acronym
- TONE
- Status last verified
- Feb 2025
- First submitted
- 24 Jul 2023
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The TONE Study: A Prospective Post-Market Clinical Study Investigating Repigmentation of Stable Vitiligo Lesions Using Spray-On Skin™ Cells
- ClinicalTrials.gov ID
- NCT05971381
- Acronym / sponsor ID
- TONE / CTP010
- Conditions
- Vitiligo
- Keywords
- focal vitiligo, segmental vitiligo, nonsegmental vitiligo, generalized vitiligo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Avita MedicalIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Treatment | Other | Device: RECELL® Autologous Cell Harvesting DeviceSkin cell suspension prepared using the RECELL System will be applied to a prepared treatment area, followed by at-home NB-UVB phototherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
- The patient has a depigmented area available for treatment that is:
- 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 (52 weeks).
Key exclusion criteria (13 listed)
- The patient is unable to undergo treatment area preparation.
- Patients who received RECELL treatment for vitiligo in Protocol No. CTP008 or CTP009.
- Patients with:
- Patients with recent history (within previous 12 months) of:
- Patients with a history of keloid formation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RECELL® Autologous Cell Harvesting DeviceAlso: Spray-On SkinTM CellsThe 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. | Device | Study Treatment |
Primary outcome
Repigmentation 0%,1-25%, 26-50%, 51-79%, 80-99%, and 100%)
Time frame: 24 weeks post-treatment
Central Review Committee categorization of index area repigmentation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RECELL® Autologous Cell Harvesting Device in people with Vitiligo, run by Avita Medical at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repigmentation 0%,1-25%, 26-50%, 51-79%, 80-99%, and 100%) (time frame: 24 weeks post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.