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Clinical Study to Investigate the Safety and Effectiveness of RECELL for Repigmentation of Stable Vitiligo Lesions

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ClinicalTrials.gov Identifier: NCT04547998
Recruitment Status : Recruiting
First Posted : September 14, 2020
Last Update Posted : September 20, 2021
Sponsor:
Information provided by (Responsible Party):
Avita Medical

Brief Summary:
This is a Prospective Blinded Within-Subject Randomized Study to evaluate the application of Spray-On Skin™ Cells, prepared using the RECELL® Device for safe and effective repigmentation of ablated stable vitiligo lesions.

Condition or disease Intervention/treatment Phase
Vitiligo Procedure: Spray-On Skin™ Cells 1:20 with NB-UVB Device: NB-UVB only Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Blinded Within-Subject Randomized Controlled Clinical Study to Investigate the Safety and Effectiveness of RECELL for Repigmentation of Stable Vitiligo Lesions
Actual Study Start Date : September 10, 2020
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Vitiligo
MedlinePlus related topics: Vitiligo

Arm Intervention/treatment
Experimental: Spray-On Skin™ Cells 1:20 with NB-UVB
Skin cell suspension at expansion ratio 1:20 (donor area : recipient area), prepared using the RECELL System, will be applied to an ablated (de-epithelialized) area of depigmentation, followed by targeted phototherapy using NB-UVB. Each participant receive treatment of a portion of a single bisected depigmented lesion or all of a single with cell suspension prepared at 1:20.
Procedure: Spray-On Skin™ Cells 1:20 with NB-UVB
Skin cell suspension at 3 expansion ratios (donor area : recipient area), prepared using the RECELL System, will be applied to an ablated (de-epithelialized) area of depigmentation, followed by targeted phototherapy using NB-UVB. Each participant will be randomized to receive treatment of a portion of their depigmented lesion with cell suspension prepared at 1:20

Active Comparator: NB-UVB only
Each subject will serve as their own control, with a portion of the depigmented lesion receiving no RECELL treatment but receiving the same targeted NB-UVB as the investigational treatment area.
Device: NB-UVB only
Each subject will serve as their own control, with a portion of the depigmented lesion receiving no RECELL treatment but receiving the same targeted NB-UVB as the investigational treatment area.




Primary Outcome Measures :
  1. Proportion of Responders for RECELL-treated areas versus Control at Week 24 [ Time Frame: Week 24 ]
    Responders are defined as study areas achieving ≥ 80% repigmentation as determined by the the Central Review Committee.


Secondary Outcome Measures :
  1. Central Review Committee categorization of repigmentation [ Time Frame: Week 24 ]
    Central Review Committee categorization of repigmentation (0-25%, 26-50%, 51-79% and 80-100%) at Week 24

  2. Central review committee assessment of color matching at Week 24 [ Time Frame: Week 24 ]
    Color matching will be rated excellent, good, moderate, or poor

  3. Subject and Investigator global treatment success and donor site satisfaction [ Time Frame: Week 24 ]
    Subjects and Investigators to respond to satisfaction questions for their treatment areas and donor sites.

  4. Subject-reported Vitiligo Noticeability Score for Week 24 vs baseline [ Time Frame: Week 24 ]
    Based upon photographs subject will report their vitiligo noticeability

  5. Investigator assessment of pigmentation responder for the study areas [ Time Frame: Week 24 ]
    Investigators to assess pigmentation response for study areas where response equals 80% or greater pigmentation

  6. Investigator assessment of repigmentation category [ Time Frame: Week 24 ]
    Investigator to look at subject photos and determine what percent the area has repigmented: 0-25, 26-50, 50-79 or 80-100

  7. Central Review Committee and Investigator assessment of pigmentation [ Time Frame: Week 36 and 52 ]
    Central Review Committee and Investigator assessment of pigmentation for the study areas at Week 36 and Week 52

  8. Investigator study area Vitiligo Area Scoring Index (VASI) scores, change from baseline [ Time Frame: Week 24 ]
    Evaluation of VASI score in study areas and change in score from pre-treatment

  9. Investigator assessment of color matching for the study areas [ Time Frame: Week 24 ]
    Color matching will be categorized as poor (0), moderate (1), good (2), or excellent (3). Hypopigmentation and hyperpigmentation, when present, will also be reported.

  10. Central Review Committee assessment of color matching [ Time Frame: Week 36 and 52 ]
    Central Review Committee assessment of color matching for the study areas at Week 36 and 52

  11. Patient Global Impression of Change - Vitiligo (PaGIC-V) [ Time Frame: Week 24 ]
    The subject's impression of their improvement is assessed using a 7-point scale

  12. Repigmentation durability [ Time Frame: Week 52 ]
    Repigmentation durability to be assessed by the Investigator and Central Review Committee (CRC). For RECELL responding study areas (i.e., study areas that achieved repigmentation at Week 24), the investigator and CRC will confirm by observation at the Week 52 visit, that at least 80% of the repigmentation remains relative to the subject's Week 24 photograph.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. 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, regardless of whether the areas are intended to be used as study areas.

1a. Photo documentation (current and at least 12 months prior) of the patient's depigmented areas have been evaluated as stable by an independent Screening Committee.

2. The patient has not undergone topical treatment (e.g., steroids, tacrolimus) for the study areas within the past 90 days.

3. The patient has not undergone phototherapy (e.g., NB-UVB) for the study areas within the past 90 days.

4. The patient is a candidate for surgical intervention of a depigmented area, defined as a patient who has previously been compliant with but has not satisfactorily responded to both

a. topical therapy and b. a minimum of 3 months of phototherapy.

5. The patient must have two study areas available for treatment that:

  1. are of similar size (±50%),
  2. are between 16cm2 and 456cm2 (contiguous),
  3. are similarly sun exposed,
  4. have the same extent of leukotrichia, and
  5. are judged clinically as ≥90% depigmented (by area).

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

    7. The patient is willing and able to comply with post-treatment at-home phototherapy and all follow-up evaluations required by the study protocol.

    8. The patient agrees to abstain from any other treatment of the study areas for the duration of his/her participation in the study (52 weeks).

    9. 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).

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

a. Understand the full nature and purpose of the study, including possible risks and adverse events, b. Understand instructions, and c. Provide voluntary written informed consent.

Exclusion Criteria:

  1. The study areas selected have concomitant dermatologic conditions other than vitiligo.
  2. The study area selected for treatment includes the lips, eyelids, plantar surface of feet, palmar surface of hands, fingertips, wrists, ankles, elbows, or knees.
  3. The patient is unable to undergo the treatment area preparation.
  4. Patients who are pregnant.
  5. Patients with:

    1. universalis vitiligo,
    2. depigmented areas over >30% of their body surface area,
    3. depigmented lips and fingertips (lip-tip vitiligo), or
    4. > 3 depigmented fingertips, defined as depigmentation of the dorsal aspect of the fingertip from the distal interphalangeal joint to the tip of the digit.
  6. Patients with recent history (within previous 12 months) of:

    1. Koebnerization,
    2. confetti-like, or
    3. trichrome lesions.
  7. Patients with a history of keloid formation.
  8. Patients who have used a tanning salon in the past 60 days.
  9. The patient has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives.
  10. 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.
  11. The patient has a known hypersensitivity to trypsin or compound sodium lactate for irrigation (Hartmann's) solution.
  12. Life expectancy is less than 1 year.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04547998


Contacts
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Contact: Elizabeth Kirshner 6613676869 ekirshner@avitamedical.com
Contact: Lisa Carothers 6614814663 lcarothers@avitamedical.com

Locations
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United States, California
University of California, Irvine Recruiting
Irvine, California, United States, 92697
Contact: Laura Ortiz       ulloal@hs.uci.edu   
Principal Investigator: Anand Ganesan, MD         
Keck School of Medicine, USC Dept of Dermatology Recruiting
Los Angeles, California, United States, 90033
Contact: Giselle Garcia    323-742-3240    Giselle.Garcia@med.usc.edu   
Principal Investigator: Nada Elbuluk, MD, MSc, FAAD         
University of California, Davis Recruiting
Sacramento, California, United States, 95817
Contact: Iryna Rybak       irybak@ucdavis.edu   
Principal Investigator: Victor Huang, MD         
West Dermatology Recruiting
San Diego, California, United States, 92121
Contact: Alexes Gonzalez    858-657-1004    agonzalez@clderm.com   
Principal Investigator: Mitchel P Goldman, MD         
United States, Colorado
AboutSkin Dermatology Recruiting
Greenwood Village, Colorado, United States, 80111
Contact: Debbie Dahler       ddahler@aboutskinderm.com   
Principal Investigator: Joel Cohen, MD         
United States, Connecticut
Modern Dermatology Recruiting
Westport, Connecticut, United States, 06880
Contact: Alessia Giannini    203-635-0770    Research Modern Dermatology <research@moderndermct.com>   
Principal Investigator: Deanne Robinson, MD, FAAD         
United States, Florida
Skin Care Research, LLC Recruiting
Hollywood, Florida, United States, 33021
Contact: Lori Aptekar       lori.aptekar.scr@gmail.com   
Principal Investigator: Eduardo Weiss, MD         
Miami Dermatology and Laser Institute Active, not recruiting
Miami, Florida, United States, 33173
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Moriel Daniel    312-503-5916    morieldaniel@northwestern.edu   
Principal Investigator: Roopal V Kundu, MD         
United States, Massachusetts
University of Massachusetts Recruiting
Worcester, Massachusetts, United States, 01581
Contact: Celia Hartigan       Celia.Hartigan@umassmed.edu   
Principal Investigator: Bassel Mahmoud, MD, PhD, FAAD         
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Jennifer Creasor, RN    313-916-0427    JCreaso2@hfhs.org   
Principal Investigator: Iltefat Hamzavi, MD         
United States, New Jersey
Skin Laser and Surgery Specialists Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Diana Aranzazu    908-359-8980    Diana.Aranzazu@schweigerderm.com   
Principal Investigator: David J Goldberg, MD         
United States, North Carolina
Dermatology, Laser & Vein Specialists of the Carolinas Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Razia Ludin, MHA,BSc, CCRC    704-973-3687    RaziaL@carolinaskin.com   
Principal Investigator: Girish Munavalli, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Deanna DeHoff       dehoff@musc.edu   
Principal Investigator: Steven Kahn, MD         
United States, Texas
University of Texas at Austin Dell Medical School Recruiting
Austin, Texas, United States, 78712
Contact: Kate Sebastian, RN,MPH       kate.sebastian@austin.utexas.edu   
Principal Investigator: Ammar Ahmed, MD         
Heights Dermatology Recruiting
Houston, Texas, United States, 77008
Contact: Ginger Bliss       gbliss@researchdrc.com   
Principal Investigator: Alpesh Desai, DO         
Sponsors and Collaborators
Avita Medical
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Responsible Party: Avita Medical
ClinicalTrials.gov Identifier: NCT04547998    
Other Study ID Numbers: CTP009
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: September 20, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases