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

Completed · Not applicable

Conditions studied: Vitiligo

In brief

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

Key facts

Study ID

NCT05971381

Run by

Avita Medical

People needed

109

Starts

2023-08-14

Expected to finish

2025-01-31

Last updated by the study team

2025-02-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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,
• Understand instructions and be able to comprehend and complete study questionnaires, and
• Provide voluntary written informed consent. -

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 -

Where it is running

• 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

Full record on ClinicalTrials.gov

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