VitiligoNCT04271501
Feasibility Study to Evaluate RECELL and Melanocyte Keratinocyte Transplantation Procedure for Repigmentation of Stable Vitiligo Lesions
A study testing Melanocyte-Keratinocyte Transplantation and Ultraviolet Lamp (UVB), RECELL 1:5 and Ultraviolet Lamp (UVB) and RECELL 1:10 and Ultraviolet Lamp (UVB) in people with Vitiligo, run by Avita Medical at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Vitiligo
- What is being tested?
- Melanocyte-Keratinocyte Transplantation and Ultraviolet Lamp (UVB), RECELL 1:5 and Ultraviolet Lamp (UVB) and RECELL 1:10 and Ultraviolet Lamp (UVB)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2020to 24 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria to be eligible:
- 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).
- The patient has not undergone topical treatment (e.g., steroids) for the study lesion within the past 60 days.
- The patient has not undergone phototherapy (e.g., NB-UVB) for the study lesion within the past 6 months.
- 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.
- Five discrete 3cm by 3cm areas are available for treatment within the depigmented lesion.
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- The 5 study areas must be similarly sun exposed.
- The extent of leukotrichia must be similar between the five study areas.
- The patient is ≥ 22 years of age.
- 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 the his/her participation in the study (24 weeks).
- 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).
- In the opinion of the investigator, the patient and/or guardian must be able to:
- Understand the full nature and purpose of the study, including possible risks and adverse events,
- Understand instructions, and
- Provide voluntary written informed consent.
Who cannot join
- Subjects who meet any of the following criteria are not eligible:
- The area requiring treatment is not associated with vitiligo.
- Study areas contain the distal phalanges.
- The patient in unable to undergo the treatment area preparation.
- Patients who are pregnant.
- Patients with universalis vitiligo, depigmented areas over >30% of their body surface area, or depigmented lips and fingertips (lip-tip vitiligo).
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- Patient 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 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.
- The patient has recent history (within 12 months) of Koebner phenomenon and/or confetti-like or trichrome lesions.
- Life expectancy is less than 1 year
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts
Worcester, Massachusetts, 01655
About this study
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
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.
- Conditions
- Vitiligo
- Being tested
- Melanocyte-Keratinocyte Transplantation and Ultraviolet Lamp (UVB), RECELL 1:5 and Ultraviolet Lamp (UVB), RECELL 1:10 and Ultraviolet Lamp (UVB), RECELL 1:20 and Ultraviolet Lamp (UVB)
- Keywords
- Vitiligo
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melanocyte-Keratinocyte Transplantation and Ultraviolet Lamp (UVB)Procedure or surgery
Application of melanocytes (aka melanocyte-keratinocyte transplantation procedure or MKTP) to surgically prepared depigmented areas
RECELL 1:5 and Ultraviolet Lamp (UVB)Device
Skin cell suspension dilution prepared using the RECELL System applied to a surgically prepared area of depigmentation
RECELL 1:10 and Ultraviolet Lamp (UVB)Device
Skin cell suspension dilution prepared using the RECELL System applied to a surgically prepared area of depigmentation
RECELL 1:20 and Ultraviolet Lamp (UVB)Device
Skin cell suspension dilution prepared using the RECELL System applied to a surgically prepared area of depigmentation
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Area without surgical intervention. Ultraviolet Lamp (UVB) |
| Melanocyte-Keratinocyte Transplantation | Active comparator | Autologous skin cell suspension prepared by laboratory based melanocyte-keratinocyte transplantation procedure technique applied to a surgically prepared area of depigmentation Receives: Procedure: Melanocyte-Keratinocyte Transplantation and Ultraviolet Lamp (UVB) |
| RECELL 1:5 | Experimental | Regenerative epidermal suspension diluted 1:5 applied to a surgically prepared area of depigmentation Receives: Device: RECELL 1:5 and Ultraviolet Lamp (UVB) |
| RECELL 1:10 | Experimental | Regenerative epidermal suspension diluted 1:10 applied to a surgically prepared area of depigmentation Receives: Device: RECELL 1:10 and Ultraviolet Lamp (UVB) |
| RECELL 1:20 | Experimental | Regenerative epidermal suspension diluted 1:20 applied to a surgically prepared area of depigmentation Receives: Device: RECELL 1:20 and Ultraviolet Lamp (UVB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repigmentation
Percent area repigmented for each study area compared to standardized reference photos by a Blinded Evaluator
Measured: 24 weeks
Secondary outcomes (4)
Categorization of Repigmentation
Categorization of each study area in terms of ranges of percent repigmentation by a Blinded Evaluator (0-25%, 26-50%, 51-79%, 80-100%)
Measured: 4, 12 and 24 weeks
Responders
Proportion of treated lesions achieving ≥80% or <80% repigmentation as assessed by a Blinded Evaluator.
Measured: 24 weeks
Subject Repigmentation Rating
Ratings of poor, moderate, good, or excellent
Measured: 4, 12 and 24 weeks
Blinded Evaluator Color Matching
Assessment of color matching (0-3: poor, moderate, good, excellent) inclusive of hypopigmentation and hyperpigmentation
Measured: 4, 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start25 Sep 2020
- Primary completion24 Aug 2021
- Study completion24 Aug 2021
Why it stopped: Suspended and Terminated to focus on CTP009 (NCT04547998) Clinical Study to Investigate the Safety and Effectiveness of RECELL for Repigmentation of Stable Vitiligo Lesions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Each subject serves as their own control.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avita Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04271501
- Sponsor's protocol ID
- CTP008
- Status last verified
- Mar 2023
- First submitted
- 13 Feb 2020
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04271501
- Acronym / sponsor ID
- CTP008
- Conditions
- Vitiligo
- Keywords
- Vitiligo
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Suspended and Terminated to focus on CTP009 (NCT04547998) Clinical Study to Investigate the Safety and Effectiveness of RECELL for Repigmentation of Stable Vitiligo Lesions
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Avita MedicalIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 24 Aug 2021 (actual)
- Study completion
- 24 Aug 2021 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
- Model description
- Each subject serves as their own control.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Area without surgical intervention. Ultraviolet Lamp (UVB) |
| Melanocyte-Keratinocyte Transplantation | Active comparator | Procedure: Melanocyte-Keratinocyte Transplantation and Ultraviolet Lamp (UVB)Autologous skin cell suspension prepared by laboratory based melanocyte-keratinocyte transplantation procedure technique applied to a surgically prepared area of depigmentation |
| RECELL 1:5 | Experimental | Device: RECELL 1:5 and Ultraviolet Lamp (UVB)Regenerative epidermal suspension diluted 1:5 applied to a surgically prepared area of depigmentation |
| RECELL 1:10 | Experimental | Device: RECELL 1:10 and Ultraviolet Lamp (UVB)Regenerative epidermal suspension diluted 1:10 applied to a surgically prepared area of depigmentation |
| RECELL 1:20 | Experimental | Device: RECELL 1:20 and Ultraviolet Lamp (UVB)Regenerative epidermal suspension diluted 1:20 applied to a surgically prepared area of depigmentation |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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).
- The patient has not undergone topical treatment (e.g., steroids) for the study lesion within the past 60 days.
- The patient has not undergone phototherapy (e.g., NB-UVB) for the study lesion within the past 6 months.
- 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.
- Five discrete 3cm by 3cm areas are available for treatment within the depigmented lesion.
Key exclusion criteria (13 listed)
- The area requiring treatment is not associated with vitiligo.
- Study areas contain the distal phalanges.
- The patient in unable to undergo the treatment area preparation.
- Patients who are pregnant.
- Patients with universalis vitiligo, depigmented areas over >30% of their body surface area, or depigmented lips and fingertips (lip-tip vitiligo).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melanocyte-Keratinocyte Transplantation and Ultraviolet Lamp (UVB)Application of melanocytes (aka melanocyte-keratinocyte transplantation procedure or MKTP) to surgically prepared depigmented areas | Procedure or surgery | Melanocyte-Keratinocyte Transplantation |
| RECELL 1:5 and Ultraviolet Lamp (UVB)Skin cell suspension dilution prepared using the RECELL System applied to a surgically prepared area of depigmentation | Device | RECELL 1:5 |
| RECELL 1:10 and Ultraviolet Lamp (UVB)Skin cell suspension dilution prepared using the RECELL System applied to a surgically prepared area of depigmentation | Device | RECELL 1:10 |
| RECELL 1:20 and Ultraviolet Lamp (UVB)Skin cell suspension dilution prepared using the RECELL System applied to a surgically prepared area of depigmentation | Device | RECELL 1:20 |
Primary outcome
Repigmentation
Time frame: 24 weeks
Percent area repigmented for each study area compared to standardized reference photos by a Blinded Evaluator
4 secondary outcomes
Categorization of Repigmentation
Time frame: 4, 12 and 24 weeks
Responders
Time frame: 24 weeks
Subject Repigmentation Rating
Time frame: 4, 12 and 24 weeks
Blinded Evaluator Color Matching
Time frame: 4, 12 and 24 weeks
Results and safety
The study was stopped early (reason given: Suspended and Terminated to focus on CTP009 (NCT04547998) Clinical Study to Investigate the Safety and Effectiveness of RECELL for Repigmentation of Stable Vitiligo Lesions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melanocyte-Keratinocyte Transplantation and Ultraviolet Lamp (UVB), RECELL 1:5 and Ultraviolet Lamp (UVB) and RECELL 1:10 and Ultraviolet Lamp (UVB) in people with Vitiligo, run by Avita Medical at 1 site 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 16 inclusion and 13 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: stopped early, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: Suspended and Terminated to focus on CTP009 (NCT04547998) Clinical Study to Investigate the Safety and Effectiveness of RECELL for Repigmentation of Stable Vitiligo Lesions). Results are not available in the source record.
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?
Repigmentation (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Mar 2023.