Non-segmental VitiligoNCT03022019
ReNovaCell in Non-segmental Vitiligo
A study testing ReNovaCell in people with Non-segmental Vitiligo and Vitiligo, run by Netherlands Institute for Pigment Disorders at 1 site in Netherlands.
Trial summary
Rationale: Autologous epidermal cell suspension grafting is an effective method of surgical treatment in vitiligo, which is suitable for treating large areas with good cosmetic results. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-segmental Vitiligo, Vitiligo
- What is being tested?
- ReNovaCell
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2016to 14 May 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with, non-segmental vitiligo receiving 6 months of standard of care, consisting of topical corticosteroids or immune modulators and NB-UVB phototherapy
- Age ≥18
- Patient is willing and able to give written informed consent
- At least two comparable (in location and diameter) depigmented lesions of at least 10 cm2 or one large lesion of at least 30 cm2 on the extremities, face or trunk.
Who cannot join
- Patients with signs of activity (spreading of lesions and/or koebnerisation) during standard of care treatment or showing depigmentation in the test punch grafting
- Skin type I
- Recurrent HSV skin infections
- Hypertrophic scars
- Keloid
- Cardiac insufficiency
Show all 12Show fewer
- Patients with a history of hypersensitivity to (UVB or UVA) light and/or allergy to local anaesthesia.
- Patients who are pregnant or breast-feeding
- Patients not competent to understand what the procedures involves
- Patients with a personal history of melanoma or non-melanoma skin cancer
- Patients with atypical nevi.
- Known allergy to clarithromycin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Autologous Cell Suspension Grafting Using ReNovaCell in Non-segmental Vitiligo Patients: a Randomized Controlled Study
Rationale:
Autologous epidermal cell suspension grafting is an effective method of surgical treatment in vitiligo, which is suitable for treating large areas with good cosmetic results. The RenovaCell Autologous Cell Harvesting Device (Avita Medical Europe Limited, Cambridge, UK) (previous name: ReCell) is a device which, compared to other forms of autologous epidermal cell suspension grafting, is easier in use showing similar results. Efficacy and safety of the ReCell device was proven in segmental vitiligo and piebaldism. However, the efficacy in non-segmental vitiligo is not yet confirmed in randomized controlled trials. The investigators hypothesize that grafting using the ReNovaCell device in combination with standard of care is also effective in stable non-segmental vitiligo and more effective than standard of care alone.
Read more
Objective:
Primary: to assess the efficacy and safety of ReNovaCell grafting combined with 311 nm UVB therapy and topical anti-inflammatory therapy for the treatment of stable non-segmental vitiligo. Secondary: to assess, satisfaction, cosmetic acceptability, noticeability and persistence of repigmentation after ReNovaCell transplantation.
Study design: Prospective, observer-blinded, randomised, within subject, controlled, study.
Study population: 20 patients ≥ 18 years with stable non-segmental vitiligo receiving standard of care (311 nm UVB therapy and topical anti-inflammatory therapy) for at least 6 months at the Netherlands Institute for Pigment Disorders (NIPD) at the Academic Medical Centre, University of Amsterdam.
Intervention: In patients already receiving standard of care (311 nm UVB therapy + topical anti-inflammatory therapy) 2 comparable depigmented regions are randomised to receive ReNovaCell grafting or no grafting. Standard of care will be given according to the standard treatment protocol of our institute.
Main study parameters/endpoints:
Primary outcome:
Objective assessment of the degree of repigmentation three and six months after ReNovaCell grafting with a digital image analysis system. To assess the pigmentation, the contours of pigmentation are copied on a transparent sheet before, three and six months after treatment, after which the sheets are scanned and digital image analysis is used to compute the affected surface. By comparing pre- and post-treatment pictures, the relative surface showing repigmentation expressed as percentage of the selected treated patch is computed.
Secondary outcomes:
- Patient Reported Outcomes: satisfaction, cosmetic acceptability, noticeability
- General patient assessed outcome per treatment region on a scale from 0-3 (poor, moderate, good or excellent).
- Visual assessment of percentage repigmentation by blinded observer and color match to normal skin
- Visual assessment of side effects per treatment region (hyperpigmentation, hypopigmentation and scarring on a scale from 0-3) by a blinded investigator.
- A small amount of the suspension of the included patients and the redundant lesional punchgrafts of all patients will be used for flow cytometric analyses of the cellular composition of the grafted cell suspension, and expression analysis of melanin synthesis-related genes. These data will be correlated to the clinical data.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: As the study involves large depigmented lesions, which are too large to treat in regular surgical treatment (punch grafting), patients will not miss any regular treatment. The time investment for the patient will be approximately 20 minutes for the punchgrafting session, 75 minutes for the cell suspension grafting session and 15 minutes for the three follow-up visits. Two of the five visits are part of the standard of care UVB follow-up regimen and are therefore not additional due to the study. Infection in the grafted area or the donor site may occur but is very rare; the risk of mild textural changes in the donor site is moderate. Hyperpigmentation of the treated area does occur often, although this improves over time in most cases. In case of improvement of the depigmentation, patients may receive another treatment for the (contralateral) untreated side.
- Conditions
- Non-segmental Vitiligo, Vitiligo
- Being tested
- ReNovaCell
- Keywords
- autologous cell suspension grafting, vitiligo, non-segmental, ReNovaCell
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReNovaCellDevice
Also called Autologous cell suspension grafting
| Study group | Role | What they receive |
|---|---|---|
| No ReNovaCell treatment | No intervention | Lesion on the same patient that receives only standard therapy, no ReNovaCell treatment. |
| ReNovaCell treatment | Experimental | Lesion on the same patient that receives the ReNovaCell treatment Receives: Device: ReNovaCell |
What is being measured
The primary outcome is the main question the study is designed to answer.
degree of repigmentation
Objective assessment of the degree of repigmentation three and six months after ReNovaCell grafting with a digital image analysis system.
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study startDec 2016
- Primary completion14 May 2019
- Study completion14 May 2019
Why it stopped: Futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-segmental 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Netherlands Institute for Pigment Disorders
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Avita Medical
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03022019
- Sponsor's protocol ID
- NL57683.018.16
- Status last verified
- Sep 2019
- First submitted
- 12 Jan 2017
- Last updated
- 16 Sep 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Cell Suspension Grafting Using ReNovaCell in Non-segmental Vitiligo Patients: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03022019
- Acronym / sponsor ID
- NL57683.018.16
- Conditions
- Non-segmental Vitiligo, Vitiligo
- Keywords
- autologous cell suspension grafting, vitiligo, non-segmental, ReNovaCell
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Netherlands Institute for Pigment DisordersUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Avita Medical
- Study start
- Dec 2016 (actual)
- Primary completion
- 14 May 2019 (actual)
- Study completion
- 14 May 2019 (actual)
- First posted
- 16 Jan 2017 (estimated)
- 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.
Rationale:
Autologous epidermal cell suspension grafting is an effective method of surgical treatment in vitiligo, which is suitable for treating large areas with good cosmetic results. The RenovaCell Autologous Cell Harvesting Device (Avita Medical Europe Limited, Cambridge, UK) (previous name: ReCell) is a device which, compared to other forms of autologous epidermal cell suspension grafting, is easier in use showing similar results. Efficacy and safety of the ReCell device was proven in segmental vitiligo and piebaldism. However, the efficacy in non-segmental vitiligo is not yet confirmed in randomized controlled trials. The investigators hypothesize that grafting using the ReNovaCell device in combination with standard of care is also effective in stable non-segmental vitiligo and more effective than standard of care alone.
Objective:
Primary: to assess the efficacy and safety of ReNovaCell grafting combined with 311 nm UVB therapy and topical anti-inflammatory therapy for the treatment of stable non-segmental vitiligo. Secondary: to assess, satisfaction, cosmetic acceptability, noticeability and persistence of repigmentation after ReNovaCell transplantation.
Study design: Prospective, observer-blinded, randomised, within subject, controlled, study.
Study population: 20 patients ≥ 18 years with stable non-segmental vitiligo receiving standard of care (311 nm UVB therapy and topical anti-inflammatory therapy) for at least 6 months at the Netherlands Institute for Pigment Disorders (NIPD) at the Academic Medical Centre, University of Amsterdam.
Intervention: In patients already receiving standard of care (311 nm UVB therapy + topical anti-inflammatory therapy) 2 comparable depigmented regions are randomised to receive ReNovaCell grafting or no grafting. Standard of care will be given according to the standard treatment protocol of our institute.
Main study parameters/endpoints:
Primary outcome:
Objective assessment of the degree of repigmentation three and six months after ReNovaCell grafting with a digital image analysis system. To assess the pigmentation, the contours of pigmentation are copied on a transparent sheet before, three and six months after treatment, after which the sheets are scanned and digital image analysis is used to compute the affected surface. By comparing pre- and post-treatment pictures, the relative surface showing repigmentation expressed as percentage of the selected treated patch is computed.
Secondary outcomes:
- Patient Reported Outcomes: satisfaction, cosmetic acceptability, noticeability
- General patient assessed outcome per treatment region on a scale from 0-3 (poor, moderate, good or excellent).
- Visual assessment of percentage repigmentation by blinded observer and color match to normal skin
- Visual assessment of side effects per treatment region (hyperpigmentation, hypopigmentation and scarring on a scale from 0-3) by a blinded investigator.
- A small amount of the suspension of the included patients and the redundant lesional punchgrafts of all patients will be used for flow cytometric analyses of the cellular composition of the grafted cell suspension, and expression analysis of melanin synthesis-related genes. These data will be correlated to the clinical data.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: As the study involves large depigmented lesions, which are too large to treat in regular surgical treatment (punch grafting), patients will not miss any regular treatment. The time investment for the patient will be approximately 20 minutes for the punchgrafting session, 75 minutes for the cell suspension grafting session and 15 minutes for the three follow-up visits. Two of the five visits are part of the standard of care UVB follow-up regimen and are therefore not additional due to the study. Infection in the grafted area or the donor site may occur but is very rare; the risk of mild textural changes in the donor site is moderate. Hyperpigmentation of the treated area does occur often, although this improves over time in most cases. In case of improvement of the depigmentation, patients may receive another treatment for the (contralateral) untreated side.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No ReNovaCell treatment | No intervention | –Lesion on the same patient that receives only standard therapy, no ReNovaCell treatment. |
| ReNovaCell treatment | Experimental | Device: ReNovaCellLesion on the same patient that receives the ReNovaCell treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with, non-segmental vitiligo receiving 6 months of standard of care, consisting of topical corticosteroids or immune modulators and NB-UVB phototherapy
- Age ≥18
- Patient is willing and able to give written informed consent
- At least two comparable (in location and diameter) depigmented lesions of at least 10 cm2 or one large lesion of at least 30 cm2 on the extremities, face or trunk.
Key exclusion criteria (12 listed)
- Patients with signs of activity (spreading of lesions and/or koebnerisation) during standard of care treatment or showing depigmentation in the test punch grafting
- Skin type I
- Recurrent HSV skin infections
- Hypertrophic scars
- Keloid
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 |
|---|---|---|
| ReNovaCellAlso: Autologous cell suspension grafting | Device | ReNovaCell treatment |
Primary outcome
degree of repigmentation
Time frame: 3 and 6 months
Objective assessment of the degree of repigmentation three and six months after ReNovaCell grafting with a digital image analysis system.
Results and safety
The study was stopped early (reason given: Futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
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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 ReNovaCell in people with Non-segmental Vitiligo and Vitiligo, run by Netherlands Institute for Pigment Disorders at 1 site in Netherlands.
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 4 inclusion and 12 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 16 Sep 2019. 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 Netherlands. 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: Futility). 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?
degree of repigmentation (time frame: 3 and 6 months). 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 16 Sep 2019.