Status:
COMPLETED
Repigmentation of Stable Vitiligo Lesions Using Spray-On Skin™ Cells
Lead Sponsor:
Avita Medical
Conditions:
Vitiligo
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To evaluate repigmentation and quality of life after treatment of stable vitiligo lesions using the RECELL Device.
Detailed 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 t...
Eligibility Criteria
Inclusion
- 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. -
Exclusion
- 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 -
Key Trial Info
Start Date :
August 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2025
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT05971381
Start Date
August 14 2023
End Date
January 31 2025
Last Update
February 6 2025
Active Locations (17)
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1
Affiliated Dermatology
Scottsdale, Arizona, United States, 85225
2
University of California, Irvine
Irvine, California, United States, 92697
3
West Dermatology Research Center
San Diego, California, United States, 92121
4
Sutter Health
Sunnyvale, California, United States, 94086