The trial is taking place at:
U

University of Massachusetts | Chan Medical School - Aaron Lazare Medical Research Building - Dermatology Department

Veeva-enabled site

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

A

AVITA Medical

Status

Active, not recruiting

Conditions

Vitiligo

Treatments

Device: RECELL® Autologous Cell Harvesting Device

Study type

Interventional

Funder types

Industry

Identifiers

NCT05971381
CTP010

Details and patient eligibility

About

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

Full 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).

Enrollment

109 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 -

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

109 participants in 1 patient group

Study Treatment
Other group
Description:
Skin cell suspension prepared using the RECELL System will be applied to a prepared treatment area, followed by at-home NB-UVB phototherapy.
Treatment:
Device: RECELL® Autologous Cell Harvesting Device

Trial contacts and locations

19

Loading...

Central trial contact

Elizabeth Kirshner

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems