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Multi-Arm 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 : April 6, 2021
Sponsor:
Information provided by (Responsible Party):
Avita Medical

Study Description
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Brief Summary:
This is a Prospective Multi-Arm Blinded Evaluator 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 1:5 with NB-UVB Procedure: Spray-On Skin™ Cells 1:10 with NB-UVB Procedure: Spray-On Skin™ Cells 1:20 with NB-UVB Device: NB-UVB only Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Multi-Arm Blinded Evaluator 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

Arms and Interventions
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Arm Intervention/treatment
Experimental: Spray-On Skin™ Cells 1:5 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 1:5.
 Procedure: Spray-On Skin™ Cells 1:5 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 1:5
Experimental: Spray-On Skin™ Cells 1:10 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 1:10.
 Procedure: Spray-On Skin™ Cells 1:10 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 1:10
Experimental: 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.
 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.


Outcome Measures
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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 blinded evaluator.


Secondary Outcome Measures :
  1. Subject reported Vitiligo Noticeability Score (VNS) [ Time Frame: Week 24 ]
    Subject reported Vitiligo Noticeability Score for Week 24 vs baseline (based on photographs)

  2. Blinded Evaluator Repigmentation Assessment [ Time Frame: Week 24 ]
    Blinded Evaluator assessed repigmentation category (ordinal data) for the study areas at week 24

  3. Blinded Evaluator color match assessment [ Time Frame: Week 24 ]
    Blinded Evaluator color match assessment


Eligibility Criteria
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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) vitiligo photographically documented as stable (no new lesions nor lesions expanding in size within the preceding 12 months, regardless of whether the lesions are intended for treatment/control in this study).
  2. The patient has not undergone topical treatment (e.g., steroids) for the study lesion within the past 60 days.
  3. The patient has not undergone phototherapy (e.g., NB-UVB) for the study lesion within the past 6 months.
  4. The patient is a candidate for surgical intervention for treatment of a depigmented area, defined as: the patient has been compliant but has not satisfactorily responded to topical therapy and a minimum of 3 months of phototherapy.
  5. Two separate areas of the same size (±10%) available for treatment within the depigmented study lesion.
  6. The two study areas must both be similarly sun exposed.
  7. The extent of leukotrichia must be similar between the two study areas.
  8. The two study areas each have a minimum area of 16 cm2
  9. The patient is 18 years of age or older.
  10. The patient is willing and able to comply with post-treatment at-home phototherapy and all follow-up evaluations required by the study protocol.
  11. 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).
  12. 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).

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

    1. Understand the full nature and purpose of the study, including possible risks and adverse events,
    2. Understand instructions, and
    3. Provide voluntary written informed consent

Exclusion Criteria:

  1. The area requiring treatment is not associated with vitiligo.
  2. Study areas include the lips, eyelids, distal phalanges, plantar surface of feet, palmar surface of hands, wrists, ankles, elbows, or knees.
  3. The patient is unable to undergo the treatment area preparation.
  4. Patients who are pregnant.
  5. Patients with universalis vitiligo, depigmented areas over >30% of their body surface area, or depigmented fingertips.
  6. Patients with recent history within 12 months of Koebnerization, confetti-like or 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
Contacts and Locations
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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: Narinder Singh       narins1@hs.uci.edu   
Principal Investigator: Anand Ganesan, MD         
Keck School of Medicine, USC Dept of Dermatology Not yet recruiting
Los Angeles, California, United States, 90033
Contact: Brenda Cornejo    323-442-0084    Brenda.Cornejo@med.usc.edu   
Principal Investigator: Nada Elbuluk, MD, MSc, FAAD         
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
Miami Dermatology and Laser Institute Recruiting
Miami, Florida, United States, 33173
Contact: Nicole Rieth       nicoler@miamidermlaser.com   
Principal Investigator: Jill Waibel, 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 Not yet recruiting
Detroit, Michigan, United States, 48202
Contact: Iltefat Hamvazi, MD       IHamzavi@hamzavi.com   
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         
Sponsors and Collaborators
Avita Medical
More Information
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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: April 6, 2021
Last Verified: April 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