Phase
Condition
Vitiligo
Treatment
RECELL® Autologous Cell Harvesting Device
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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.
The patient is a candidate for surgical intervention of a depigmented area, definedas 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 theduration of his/her participation in the study (52 weeks).
The patient is willing and able to comply with post-treatment at-home phototherapyand all follow-up study visits.
The patient agrees to abstain from any other treatment of the study area for theduration of his/her participation in the study (52 weeks).
The patient agrees to abstain from enrollment in any other interventional clinicaltrial 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 risksand benefits,
Understand instructions and be able to comprehend and complete studyquestionnaires, and
Provide voluntary written informed consent. -
Exclusion
Exclusion Criteria:
The patient is unable to undergo treatment area preparation.
Patients who received RECELL treatment for vitiligo in Protocol No. CTP008 orCTP009.
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 investigatormay compromise patient safety or study objectives.
Current use of medications (e.g., anticoagulants such as heparin or warfarin) thatin the investigator's opinion may compromise patient safety or trial objectives.
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
Study Description
Connect with a study center
Affiliated Dermatology
Scottsdale, Arizona 85225
United StatesSite Not Available
University of California, Irvine
Irvine, California 92697
United StatesSite Not Available
University of Southern California
Los Angeles, California 90017
United StatesSite Not Available
Ablon Skin Institute & Research Center
Manhattan Beach, California 90266
United StatesSite Not Available
University of California, Davis
Sacramento, California 95816
United StatesSite Not Available
West Dermatology Research Center
San Diego, California 92121
United StatesSite Not Available
Sutter Health
Sunnyvale, California 94086
United StatesSite Not Available
California Dermatology Institute
Thousand Oaks, California 91320
United StatesSite Not Available
Clarity Dermatology
Castle Rock, Colorado 80109
United StatesSite Not Available
Howard University
Washington, District of Columbia 20060
United StatesSite Not Available
Siperstein Dermatology Group
Boynton Beach, Florida 33437
United StatesSite Not Available
Skin Care Research, LLC
Hollywood, Florida 33021
United StatesSite Not Available
University Medical Center
New Orleans, Louisiana 70122
United StatesSite Not Available
Dermatologic Surgery Center of Washington
Chevy Chase, Maryland 20815
United StatesSite Not Available
Maryland Laser, Skin & Vein Institute
Hunt Valley, Maryland 21030
United StatesSite Not Available
University Of Massachusetts
Worcester, Massachusetts 01605
United StatesSite Not Available
Hamzavi Dermatology
Canton, Michigan 48187
United StatesSite Not Available
Henry Ford Health
Detroit, Michigan 48202
United StatesSite Not Available
Grekin Skin Institute
Warren, Michigan 48088
United StatesSite Not Available
Mount Sinai
New York, New York 10028
United StatesSite Not Available
The Dermatology Specialist
New York, New York 10012
United StatesSite Not Available
Dermatology, Laser and Vein Specialists of the Carolinas
Charlotte, North Carolina 28207
United StatesSite Not Available
University of Texas at Austin
Austin, Texas 78712
United StatesSite Not Available
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