Repigmentation of Stable Vitiligo Lesions Using Spray-On Skin™ Cells
NCT ID: NCT05971381
Last Updated: 2025-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
109 participants
INTERVENTIONAL
2023-08-14
2025-01-31
Brief Summary
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Detailed Description
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Repigmentation of treatment areas will be determined via centralized image interpretation by an expert dermatological panel (i.e., Central Review Committee, CRC).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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 -
18 Years
ALL
No
Sponsors
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Avita Medical
INDUSTRY
Responsible Party
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Locations
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Affiliated Dermatology
Scottsdale, Arizona, United States
University of California, Irvine
Irvine, California, United States
West Dermatology Research Center
San Diego, California, United States
Sutter Health
Sunnyvale, California, United States
California Dermatology Institute
Thousand Oaks, California, United States
Clarity Dermatology
Castle Rock, Colorado, United States
Siperstein Dermatology Group
Boynton Beach, Florida, United States
Skin Care Research, LLC
Hollywood, Florida, United States
Dermatologic Surgery Center of Washington
Chevy Chase, Maryland, United States
Maryland Laser, Skin & Vein Institute
Hunt Valley, Maryland, United States
University Of Massachusetts
Worcester, Massachusetts, United States
Hamzavi Dermatology
Canton, Michigan, United States
Henry Ford Health
Detroit, Michigan, United States
Grekin Skin Institute
Warren, Michigan, United States
The Dermatology Specialist
New York, New York, United States
Mount Sinai
New York, New York, United States
Dermatology, Laser and Vein Specialists of the Carolinas
Charlotte, North Carolina, United States
Countries
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Other Identifiers
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CTP010
Identifier Type: -
Identifier Source: org_study_id
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