NCT04547998

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

September 10, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
8 months until next milestone

Results Posted

Study results publicly available

September 21, 2023

Completed
Last Updated

May 24, 2024

Status Verified

August 1, 2023

Enrollment Period

1.8 years

First QC Date

September 8, 2020

Results QC Date

July 24, 2023

Last Update Submit

April 29, 2024

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (1)

  • Incidence of ≥80% Study Area Repigmentation

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

    Week 24

Secondary Outcomes (2)

  • Repigmentation Category

    Week 24

  • Color Matching

    Week 24

Study Arms (1)

All Participants (within patient control)

EXPERIMENTAL

Each 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.

Device: Control Intervention (UVB)Device: Investigational Interventions (Ablative Laser Resurfacing + RECELL + UVB)

Interventions

Control Intervention (UVB)DEVICE

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

Also known as: Phototherapy
All Participants (within patient control)
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.

All Participants (within patient control)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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.
  • a. 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.
  • \. The patient has not undergone topical treatment (e.g., steroids, tacrolimus) for the study areas within the past 90 days.
  • \. The patient has not undergone phototherapy (e.g., NB-UVB) for the study areas within the past 90 days.
  • \. 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.
  • \. 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).
  • \. The patient is 18 years of age or older.
  • \. The patient is willing and able to comply with post-treatment at-home phototherapy and all follow-up evaluations required by the study protocol.
  • \. 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).
  • +3 more criteria

You may not qualify if:

  • 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,
  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

University of California, Irvine

Irvine, California, 92697, United States

Location

University of California, Davis

Sacramento, California, 95817, United States

Location

West Dermatology

San Diego, California, 92121, United States

Location

DMR Research

Westport, Connecticut, 06880, United States

Location

Skin Care Research, LLC

Hollywood, Florida, 33021, United States

Location

Miami Dermatology and Laser Institute

Miami, Florida, 33173, United States

Location

University of Massachusetts

Worcester, Massachusetts, 01581, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Dermatology, Laser & Vein Specialists of the Carolinas

Charlotte, North Carolina, 28207, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of Texas at Austin Dell Medical School

Austin, Texas, 78712, United States

Location

Heights Dermatology

Houston, Texas, 77008, United States

Location

Related Publications (1)

  • 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.

    PMID: 11782062BACKGROUND

MeSH Terms

Conditions

Vitiligo

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

Title
SVP Global Clinical Research
Organization
AVITA
ekirshner@avitamedical.com
1-833-462-8482

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
The Central Review Committee (CRC) will be blinded to treatment assignment when adjudicating data.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2020

First Posted

September 14, 2020

Study Start

September 10, 2020

Primary Completion

June 28, 2022

Study Completion

January 31, 2023

Last Updated

May 24, 2024

Results First Posted

September 21, 2023

Record last verified: 2023-08

Locations

US(12)