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

Last updated: February 4, 2025
Sponsor: Avita Medical
Overall Status: Completed

Phase

N/A

Condition

Vitiligo

Treatment

RECELL® Autologous Cell Harvesting Device

Clinical Study ID

NCT05971381
CTP010
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Focal, segmental, or generalized (i.e., nonsegmental) stable vitiligo, defined as nonew depigmented areas nor any depigmented areas that have expanded in size withinthe preceding 12 months.

  2. The patient is a candidate for surgical intervention of a depigmented area, definedas a patient who has not satisfactorily responded to either:

  3. topical therapy or

  4. a minimum of 3 months of phototherapy.

  5. The patient has a depigmented area available for treatment that is:

  6. ≥90% depigmented,

  7. without any other dermatologic conditions (other than vitiligo), and

  8. excludes the lips, eyelids, plantar surface of feet, palmar surface of hands.

  9. The patient is 18 years of age or older.

  10. The patient agrees to remain on any current use of immunosuppressive therapy for theduration of his/her participation in the study (52 weeks).

  11. The patient is willing and able to comply with post-treatment at-home phototherapyand all follow-up study visits.

  12. The patient agrees to abstain from any other treatment of the study area for theduration of his/her participation in the study (52 weeks).

  13. The patient agrees to abstain from enrollment in any other interventional clinicaltrial for the duration of his/her participation in the study (52 weeks).

  14. In the opinion of the investigator, the patient must be able to:

  15. Understand the full nature and purpose of the study, including possible risksand benefits,

  16. Understand instructions and be able to comprehend and complete studyquestionnaires, and

  17. Provide voluntary written informed consent. -

Exclusion

Exclusion Criteria:

  1. The patient is unable to undergo treatment area preparation.

  2. Patients who received RECELL treatment for vitiligo in Protocol No. CTP008 orCTP009.

  3. Patients with:

  4. depigmented lips and fingertips (lip-tip vitiligo), or

  5. depigmented areas over >30% of their body surface area.

  6. Patients with recent history (within previous 12 months) of:

  7. Koebnerization,

  8. confetti-like, or

  9. trichrome lesions.

  10. Patients with a history of keloid formation.

  11. The patient has other concurrent conditions that in the opinion of the investigatormay compromise patient safety or study objectives.

  12. Current use of medications (e.g., anticoagulants such as heparin or warfarin) thatin the investigator's opinion may compromise patient safety or trial objectives.

  13. The patient has a known hypersensitivity to trypsin, compound sodium lactate forirrigation solution (Hartmann's solution), povidone-iodine, chlorhexidine, and/orlidocaine-containing anesthetics -

Study Design

Total Participants: 109
Treatment Group(s): 1
Primary Treatment: RECELL® Autologous Cell Harvesting Device
Phase:
Study Start date:
August 14, 2023
Estimated Completion Date:
January 31, 2025

Study 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).

Connect with a study center

  • Affiliated Dermatology

    Scottsdale, Arizona 85225
    United States

    Site Not Available

  • University of California, Irvine

    Irvine, California 92697
    United States

    Site Not Available

  • University of Southern California

    Los Angeles, California 90017
    United States

    Site Not Available

  • Ablon Skin Institute & Research Center

    Manhattan Beach, California 90266
    United States

    Site Not Available

  • University of California, Davis

    Sacramento, California 95816
    United States

    Site Not Available

  • West Dermatology Research Center

    San Diego, California 92121
    United States

    Site Not Available

  • Sutter Health

    Sunnyvale, California 94086
    United States

    Site Not Available

  • California Dermatology Institute

    Thousand Oaks, California 91320
    United States

    Site Not Available

  • Clarity Dermatology

    Castle Rock, Colorado 80109
    United States

    Site Not Available

  • Howard University

    Washington, District of Columbia 20060
    United States

    Site Not Available

  • Siperstein Dermatology Group

    Boynton Beach, Florida 33437
    United States

    Site Not Available

  • Skin Care Research, LLC

    Hollywood, Florida 33021
    United States

    Site Not Available

  • University Medical Center

    New Orleans, Louisiana 70122
    United States

    Site Not Available

  • Dermatologic Surgery Center of Washington

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • Maryland Laser, Skin & Vein Institute

    Hunt Valley, Maryland 21030
    United States

    Site Not Available

  • University Of Massachusetts

    Worcester, Massachusetts 01605
    United States

    Site Not Available

  • Hamzavi Dermatology

    Canton, Michigan 48187
    United States

    Site Not Available

  • Henry Ford Health

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Grekin Skin Institute

    Warren, Michigan 48088
    United States

    Site Not Available

  • Mount Sinai

    New York, New York 10028
    United States

    Site Not Available

  • The Dermatology Specialist

    New York, New York 10012
    United States

    Site Not Available

  • Dermatology, Laser and Vein Specialists of the Carolinas

    Charlotte, North Carolina 28207
    United States

    Site Not Available

  • University of Texas at Austin

    Austin, Texas 78712
    United States

    Site Not Available

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