Your session is about to expire
← Back to Search
Procedure
Spray-On Skin Cells for Vitiligo (TONE Trial)
N/A
Waitlist Available
Research Sponsored by Avita Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks post-treatment
Awards & highlights
TONE Trial Summary
This trial tested using a device to treat vitiligo to see if it improved the skin's colour and quality of life.
Who is the study for?
This trial is for adults with stable vitiligo, which hasn't changed in the past year. They should have tried topical therapy or phototherapy without success and be willing to stick to their current immunosuppressive drugs and at-home phototherapy during the study. Participants must not use other treatments or join another trial for 24 weeks.Check my eligibility
What is being tested?
The RECELL Device is being tested to see if it can repigment skin affected by vitiligo and improve patients' quality of life. The device uses a patient's own cells to create a spray-on treatment applied to depigmented areas.See study design
What are the potential side effects?
Potential side effects may include typical risks associated with minor surgical procedures such as infection, scarring, or an allergic reaction to materials used during the process like trypsin or local anesthetics.
TONE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Repigmentation 0%,1-25%, 26-50%, 51-79%, 80-99%, and 100%)
TONE Trial Design
1Treatment groups
Experimental Treatment
Group I: Study TreatmentExperimental Treatment1 Intervention
Skin cell suspension prepared using the RECELL System will be applied to a prepared treatment area, followed by at-home NB-UVB phototherapy.
Find a Location
Who is running the clinical trial?
Avita MedicalLead Sponsor
15 Previous Clinical Trials
541 Total Patients Enrolled
4 Trials studying Vitiligo
57 Patients Enrolled for Vitiligo
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot prepare the treatment area by myself.My vitiligo is stable and not spreading.I understand the study's purpose, can complete questionnaires, and agree to participate.I am not on any medication or have conditions that could risk my safety in the study.I am eligible for surgery to treat a depigmented skin area.I can follow the at-home treatment plan and attend all follow-up visits.I have a large area of skin that has lost most of its color.I have a large area of skin without color, not including lips, eyelids, or palms/soles, and no other skin conditions.I am 18 years old or older.I can follow the at-home treatment plan and attend all follow-up visits.I understand the study's risks and benefits, can follow instructions, and am willing to consent.I am 18 years old or older.I agree to continue my current immunosuppressive therapy.I agree to continue my current immunosuppressive therapy for 24 weeks.My vitiligo has not changed in the past year.I am eligible for surgery on a skin area that didn't improve after using creams or light therapy for 3 months.My vitiligo has not worsened or spread in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Study Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the recruitment process currently ongoing for this research project?
"The data on clinicaltrials.gov reveals that this medical trial is actively searching for enrollees, with the initial posting date being July 24th 2023 and a recent update made on the 31st of July 2023."
Answered by AI
How many individuals are enrolled in this medical trial?
"Affirmative. The clinicaltrials.gov website suggests that the trial, which was originally posted on July 24th 2023, is actively recruiting patients. Approximately 100 individuals must be recruited at one single site to complete the study's objectives."
Answered by AI
Who else is applying?
What state do they live in?
New York
What site did they apply to?
Mount Sinai
University Medical Center
Howard University
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
1
0
What questions have other patients asked about this trial?
How long does the process take? I have vitiligo on my elbows and ankles, will be there a period of time for which I will be in bedrest post the surgery to allow it to heal?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
I seen it online. I would like to find the best affordable treatment. I have non-segmental vitiligo and have done skin grafting previously, I’d like to test the device if I’m eligible too.
PatientReceived no prior treatments
Hoping this will be effective for vilitigo as I've tried other topicals and have been doing excimer laser for a long time.
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Email
Phone Call
Most responsive sites:
- Skin Care Research, LLC: < 48 hours
- University Medical Center: < 48 hours
Average response time
- < 2 Days
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger