Repigmentation of Stable Vitiligo Lesions Using Spray-On Skin™ Cells
Key facts
- Where
- Boynton Beach, Canton, Castle Rock, Charlotte, Chevy Chase, Detroit, Hollywood, Hunt Valley, Irvine, New York, San Diego, Scottsdale, Sunnyvale, Thousand Oaks, Warren, and Worcester, United StatesSee the 17 sites
Where in United States
- Siperstein Dermatology GroupBoynton Beach, United StatesNo longer taking part
- Hamzavi DermatologyCanton, United StatesNo longer taking part
- Clarity DermatologyCastle Rock, United StatesNo longer taking part
- Dermatology, Laser and Vein Specialists of the CarolinasCharlotte, United StatesNo longer taking part
- Dermatologic Surgery Center of WashingtonChevy Chase, United StatesNo longer taking part
- Henry Ford HealthDetroit, United StatesNo longer taking part
- Skin Care Research, LlcHollywood, United StatesNo longer taking part
- Maryland Laser, Skin & Vein InstituteHunt Valley, United StatesNo longer taking part
- University of California, IrvineIrvine, United StatesNo longer taking part
- Mount SinaiNew York, United StatesNo longer taking part
- The Dermatology SpecialistNew York, United StatesNo longer taking part
- West Dermatology Research CenterSan Diego, United StatesNo longer taking part
- Affiliated DermatologyScottsdale, United StatesNo longer taking part
- Sutter HealthSunnyvale, United StatesNo longer taking part
- California Dermatology InstituteThousand Oaks, United StatesNo longer taking part
- Grekin Skin InstituteWarren, United StatesNo longer taking part
- University of MassachusettsWorcester, United StatesNo longer taking part
Trial details
- Who runs it
- Avita Medical
- Trial code
- NCT05971381
- Record updated
- 6 February 2025
- Original description
To evaluate repigmentation and quality of life after treatment of stable vitiligo lesions using the RECELL Device.Read full original descriptionShow less
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.
Inclusion: 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 (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. -.
Exclusion: Patients who received RECELL treatment for vitiligo in Protocol No. CTP008 or CTP009; Patients with recent history (within previous 12 months) of:; Koebnerization,; confetti-like, or; trichrome lesions; 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; Patients with a history of keloid formation; 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 -; The patient is unable to undergo treatment area preparation; Patients with:; depigmented lips and fingertips (lip-tip vitiligo), or; depigmented areas over >30% of their body surface area.