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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04547998
Recruitment Status : Active, not recruiting
First Posted : September 14, 2020
Last Update Posted : May 11, 2022
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 Device: Spray-On Skin™ Cells 1:20 followed by NB-UVB Device: NB-UVB only Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: The Central Review Committee (CRC) will be blinded to treatment assignment when adjudicating data.
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 : July 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Vitiligo
MedlinePlus related topics: Vitiligo

Arm Intervention/treatment
Experimental: All Participants (within patient control)
All subjects will receive both RECELL and NV-UVB. Each subject will serve as their own Control, with a depigmented area receiving no RECELL treatment but receiving the same targeted NB-UVB as the investigational treatment area. Study treatment areas will be randomily assigned as Area A and Area B. Investigational treatment (RECELL) will be randomly allocated to either Area A or Area B.
Device: Spray-On Skin™ Cells 1:20 followed by 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.

Device: NB-UVB only
Each subject will serve as their own control, with a portion (or similar) depigmented lesion receiving the same targeted NB-UVB without application of skin cell suspension.




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, 51-79 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


Locations
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United States, California
University of California, Irvine
Irvine, California, United States, 92697
University of California, Davis
Sacramento, California, United States, 95817
West Dermatology
San Diego, California, United States, 92121
United States, Connecticut
DMR Research
Westport, Connecticut, United States, 06880
United States, Florida
Skin Care Research, LLC
Hollywood, Florida, United States, 33021
Miami Dermatology and Laser Institute
Miami, Florida, United States, 33173
United States, Massachusetts
University of Massachusetts
Worcester, Massachusetts, United States, 01581
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, North Carolina
Dermatology, Laser & Vein Specialists of the Carolinas
Charlotte, North Carolina, United States, 28207
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
University of Texas at Austin Dell Medical School
Austin, Texas, United States, 78712
Heights Dermatology
Houston, Texas, United States, 77008
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: May 11, 2022
Last Verified: May 2022

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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