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

NCT05971381 | Completed FDA Device

• 1 other identifier: CTP010
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 17

Brief Summary

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

Conditions

Vitiligo

Keywords

focal vitiligo; segmental vitiligo; nonsegmental vitiligo; generalized vitiligo

Outcome Measures

Primary Outcomes (1)

• Repigmentation 0%,1-25%, 26-50%, 51-79%, 80-99%, and 100%)

  Central Review Committee categorization of index area repigmentation

  24 weeks post-treatment

Study Arms (1)

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.

Device: RECELL® Autologous Cell Harvesting Device

Interventions

RECELL® Autologous Cell Harvesting Device 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.

Also known as: Spray-On SkinTM Cells

Study Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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:
• 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 -

Sponsors & Collaborators

• Avita Medical: lead

Study Sites (17)

Affiliated Dermatology

Scottsdale, Arizona, 85225, United States

Location

University of California, Irvine

Irvine, California, 92697, United States

Location

West Dermatology Research Center

San Diego, California, 92121, United States

Location

Sutter Health

Sunnyvale, California, 94086, United States

Location

California Dermatology Institute

Thousand Oaks, California, 91320, United States

Location

Clarity Dermatology

Castle Rock, Colorado, 80109, United States

Location

Siperstein Dermatology Group

Boynton Beach, Florida, 33437, United States

Location

Skin Care Research, LLC

Hollywood, Florida, 33021, United States

Location

Dermatologic Surgery Center of Washington

Chevy Chase, Maryland, 20815, United States

Location

Maryland Laser, Skin & Vein Institute

Hunt Valley, Maryland, 21030, United States

Location

University Of Massachusetts

Worcester, Massachusetts, 01605, United States

Location

Hamzavi Dermatology

Canton, Michigan, 48187, United States

Location

Henry Ford Health

Detroit, Michigan, 48202, United States

Location

Grekin Skin Institute

Warren, Michigan, 48088, United States

Location

The Dermatology Specialist

New York, New York, 10012, United States

Location

Mount Sinai

New York, New York, 10028, United States

Location

Dermatology, Laser and Vein Specialists of the Carolinas

Charlotte, North Carolina, 28207, United States

Location

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 2, 2023
• Study Start: August 14, 2023
• Primary Completion: July 30, 2024
• Study Completion: January 31, 2025
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)