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VitiligoNCT04547998

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

A study testing Investigational Interventions (Ablative Laser Resurfacing + RECELL + UVB) in people with Vitiligo, run by Avita Medical at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Vitiligo
What is being tested?
Investigational Interventions (Ablative Laser Resurfacing + RECELL + UVB)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
12 sitesUnited States
Study dates
10 Sep 2020to 31 Jan 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • topical therapy and b. a minimum of 3 months of phototherapy.
Show all 18Show fewer
  • 5. The patient must have two study areas available for treatment that:
  • are of similar size (±50%),
  • are between 16cm2 and 456cm2 (contiguous),
  • are similarly sun exposed,
  • have the same extent of leukotrichia, and
  • 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:
  • 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.

Who cannot join

  • The study areas selected have concomitant dermatologic conditions other than vitiligo.
  • The study area selected for treatment includes the lips, eyelids, plantar surface of feet, palmar surface of hands, fingertips, wrists, ankles, elbows, or knees.
  • The patient is unable to undergo the treatment area preparation.
  • Patients who are pregnant.
  • Patients with:
  • universalis vitiligo,
Show all 19Show fewer
  • depigmented areas over >30% of their body surface area,
  • depigmented lips and fingertips (lip-tip vitiligo), or
  • > 3 depigmented fingertips, defined as depigmentation of the dorsal aspect of the fingertip from the distal interphalangeal joint to the tip of the digit.
  • Patients with recent history (within previous 12 months) of:
  • Koebnerization,
  • confetti-like, or
  • trichrome lesions.
  • Patients with a history of keloid formation.
  • Patients who have used a tanning salon in the past 60 days.
  • The patient has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives.
  • 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.
  • The patient has a known hypersensitivity to trypsin or compound sodium lactate for irrigation (Hartmann's) solution.
  • Life expectancy is less than 1 year.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • University of Texas at Austin Dell Medical School

    Austin, Texas, 78712

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Dermatology, Laser & Vein Specialists of the Carolinas

    Charlotte, North Carolina, 28207

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Skin Care Research, LLC

    Hollywood, Florida, 33021

  • Heights Dermatology

    Houston, Texas, 77008

  • University of California, Irvine

    Irvine, California, 92697

  • Miami Dermatology and Laser Institute

    Miami, Florida, 33173

  • University of California, Davis

    Sacramento, California, 95817

  • West Dermatology

    San Diego, California, 92121

  • DMR Research

    Westport, Connecticut, 06880

  • University of Massachusetts

    Worcester, Massachusetts, 01581

Other trials in United States

About this study

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

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.

Conditions
Vitiligo
Being tested
Control Intervention (UVB), Investigational Interventions (Ablative Laser Resurfacing + RECELL + UVB)
Medical subject headings
Vitiligo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Control Intervention (UVB)Device

    Also called Phototherapy

    Targeted narrowband-UVB phototherapy in alignment with published Vitiligo Working Group recommendations.

  • Investigational Interventions (Ablative Laser Resurfacing + RECELL + UVB)Device

    Spray-On Skin™ Cells prepared using RECELL will be applied to an area prepared by ablative laser, followed by targeted narrowband UVB phototherapy.

Study groups in NCT04547998
Study groupRoleWhat they receive
All Participants (within patient control)ExperimentalEach participant will serve as their own Control, receiving both Control and Investigational Interventions randomly allocated to treatment of a portion of a depigmented vitiligo lesion.
Receives: Device: Control Intervention (UVB); Device: Investigational Interventions (Ablative Laser Resurfacing + RECELL + UVB)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of ≥80% Study Area Repigmentation

    Repigmentation was evaluated by qualified members of a Central Review Committee.

    Measured: Week 24

Secondary outcomes (2)

  1. Repigmentation Category

    Expert Central Review Committee categorization of the amount of area repigmented (0-25%, 26-50%, 51-79% and 80-100%). This is visual estimation of the vitiligo lesion area that has repigmented, with reference to training images. Higher %repigmentation is a better outcome.

    Measured: Week 24

  2. Color Matching

    The Expert Central Review Committee visually judged the quality of repigmentation in terms of how closely it matches with the normal pigmentation seen in the surrounding area. The rating scale consists of poor, moderate, good, and excellent. Color matching can only be evaluated in instances of >0% repigmentation.

    Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2020
  2. Study start10 Sep 2020
  3. Primary completion28 Jun 2022
  4. Study completion31 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04547998
Sponsor's protocol ID
CTP009
Status last verified
Aug 2023
First submitted
8 Sep 2020
Last updated
24 May 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Liu JP, Hsueh HM, Hsieh E, Chen JJ. Tests for equivalence or non-inferiority for paired binary data. Stat Med. 2002 Jan 30;21(2):231-45. doi: 10.1002/sim.1012.

    PubMed 11782062

Questions about this trial

What is this clinical trial studying?

A study testing Investigational Interventions (Ablative Laser Resurfacing + RECELL + UVB) in people with Vitiligo, run by Avita Medical at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of ≥80% Study Area Repigmentation (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04547998, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.

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