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Feasibility Study to Evaluate RECELL and Melanocyte Keratinocyte Transplantation Procedure 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04271501
Recruitment Status : Recruiting
First Posted : February 17, 2020
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Avita Medical

Brief Summary:
Prospective randomized within-subject controlled feasibility study to evaluate the clinical performance of RECELL for repigmentation of stable, depigmented lesions. The trial will evaluate 50 matched, stable depigmented areas from 10 subjects.

Condition or disease Intervention/treatment Phase
Vitiligo Procedure: Melanocyte-Keratinocyte Transplantation and Ultraviolet Lamp (UVB) Device: RECELL 1:5 and Ultraviolet Lamp (UVB) Device: RECELL 1:10 and Ultraviolet Lamp (UVB) Device: RECELL 1:20 and Ultraviolet Lamp (UVB) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Each subject serves as their own control.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Repigmentation will be evaluated via measurement of the area repigmented and will be rated by the patient and a Blinded Evaluator (blinded to treatment allocation) using standardized photographs.
Primary Purpose: Device Feasibility
Official Title: A Prospective Blinded Randomized Within-Subject Controlled Clinical Feasibility Study to Evaluate RECELL and Melanocyte Keratinocyte Transplantation Procedure (MKTP) for Repigmentation of Stable Vitiligo Lesions
Actual Study Start Date : September 25, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Vitiligo
MedlinePlus related topics: Vitiligo

Arm Intervention/treatment
No Intervention: Control
Area without surgical intervention
Active Comparator: Melanocyte-Keratinocyte Transplantation
Autologous skin cell suspension prepared by laboratory based melanocyte-keratinocyte transplantation procedure technique applied to a surgically prepared area of depigmentation
Procedure: Melanocyte-Keratinocyte Transplantation and Ultraviolet Lamp (UVB)
Application of melanocytes (aka melanocyte-keratinocyte transplantation procedure or MKTP) to surgically prepared depigmented areas

Experimental: RECELL 1:5
Regenerative epidermal suspension diluted 1:5 applied to a surgically prepared area of depigmentation
Device: RECELL 1:5 and Ultraviolet Lamp (UVB)
Skin cell suspension dilution prepared using the RECELL System applied to a surgically prepared area of depigmentation

Experimental: RECELL 1:10
Regenerative epidermal suspension diluted 1:10 applied to a surgically prepared area of depigmentation
Device: RECELL 1:10 and Ultraviolet Lamp (UVB)
Skin cell suspension dilution prepared using the RECELL System applied to a surgically prepared area of depigmentation

Experimental: RECELL 1:20
Regenerative epidermal suspension diluted 1:20 applied to a surgically prepared area of depigmentation
Device: RECELL 1:20 and Ultraviolet Lamp (UVB)
Skin cell suspension dilution prepared using the RECELL System applied to a surgically prepared area of depigmentation




Primary Outcome Measures :
  1. Repigmentation [ Time Frame: 24 weeks ]
    Percent area repigmented for each study area compared to standardized reference photos by a Blinded Evaluator


Secondary Outcome Measures :
  1. Categorization of Repigmentation [ Time Frame: 24 weeks ]
    Categorization of each study area in terms of ranges of percent repigmentation by a Blinded Evaluator (0-25%, 26-50%, 51-79%, 80-100%)

  2. Responders [ Time Frame: 24 weeks ]
    Proportion of treated lesions achieving ≥80% or <80% repigmentation as assessed by a Blinded Evaluator.

  3. Subject Repigmentation Rating [ Time Frame: 24 weeks ]
    Ratings of poor, moderate, good, or excellent

  4. Blinded Evaluator Color Matching [ Time Frame: 24 weeks ]
    Assessment of color matching (0-3: poor, moderate, good, excellent) inclusive of hypopigmentation and hyperpigmentation



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

Inclusion Criteria:

Subjects must meet all of the following criteria to be eligible:

  1. Focal, segmental or generalized (i.e., nonsegmental) vitiligo 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 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. Five discrete 3cm by 3cm areas are available for treatment within the depigmented lesion.
  6. The 5 study areas must be similarly sun exposed.
  7. The extent of leukotrichia must be similar between the two study areas.
  8. The patient is > 22 years of age.
  9. The patient is willing and able to comply with post-treatment at-home phototherapy and all follow-up evaluations required by the study protocol.
  10. The patient agrees to abstain from any other treatment of the study areas for the duration of the his/her participation in the study (24 weeks).
  11. The patient agrees to abstain from enrollment in any other interventional clinical trial for the duration of his/her participation in the study (24 weeks).
  12. In the opinion of the investigator, the patient and/or guardian 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:

Subjects who meet any of the following criteria are not eligible:

  1. The area requiring treatment is not associated with vitiligo.
  2. Study areas contain the distal phalanges.
  3. The patient in 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. Patient with a history of keloid formation.
  7. Patients who have used a tanning salon in the past 60 days.
  8. The patient has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives.
  9. Current use of medications (e.g., anticoagulants such as such as heparin or warfarin) that in the investigator's opinion may compromise patient safety or trial objectives.
  10. The patient has a known hypersensitivity to trypsin or compound sodium lactate for irrigation (Hartmann's) solution.
  11. The patient has recent history (within 12 months) of Koebner phenomenon and/or confetti-like or trichrome lesions.
  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): NCT04271501


Contacts
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Contact: Elizabeth Kirshner 661-367-9180 ekirshner@avitamedical.com
Contact: Lisa Carothers 661-568-1311 lcarothers@avitamedical.com

Locations
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United States, Massachusetts
University of Massachusetts Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Celia Hartigan       Celia.Hartigan@umassmed.edu   
Sponsors and Collaborators
Avita Medical
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Responsible Party: Avita Medical
ClinicalTrials.gov Identifier: NCT04271501    
Other Study ID Numbers: CTP008
First Posted: February 17, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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