PiebaldismPhase 4NCT01640678
Autologous Cell Suspension Grafting Using ReCell in Vitiligo and Piebaldism Patients
A Phase 4 study testing ReCell epidermal cell suspension grafting and CO2 laser abrasion + UV-therapy in people with Piebaldism and Segmental Vitiligo, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Autologous epidermal cell suspension grafting is an effective method of surgical treatment in vitiligo, which is suitable for treating larger areas with better cosmetic results as compared to other grafting methods. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Piebaldism, Segmental Vitiligo
- What is being tested?
- ReCell epidermal cell suspension grafting and CO2 laser abrasion + UV-therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2012to Dec 2013
- Phase
- Phase 4
- 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
- patient with piebaldism
- Patients with segmental vitiligo,stable since 12 months without systemic therapy or topical therapy as defined by the absence of new lesions and/or enlargement of existing lesions
- with at least three depigmented skin lesions on the proximal extremities or trunk larger than 3x3 cm or one lesion of at least 9x3 cm
- Age >18
- willing and able to give written informed consent
Who cannot join
- UV therapy or systemic immunosuppressive treatment during the last 12 months
- Local treatment of vitiligo during the last 12 months
- Vitiligo lesions with follicular or non-follicular repigmentation
- Skin type I
- Recurrent HSV skin infections
- Hypertrophic scars
Show all 13Show fewer
- Keloid
- Cardial insufficiency
- Patients with a history of hypersensitivity to (UVB or UVA) light and/or allergy to local anesthesia.
- Patients who are pregnant or breast-feeding
- Patients not competent to understand the procedures involved
- Patients with atypical nevi
- Patients with a personal history of melanoma or non-melanoma skin cancer
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
The Netherlands Institute for pigment disorders, AMC
Amsterdam, 1105 AZ
About this study
Official title: Autologous Cell Suspension Grafting Using ReCell in Vitiligo and Piebaldism Patients: a Randomized Controlled Pilot Study
Autologous epidermal cell suspension grafting is an effective method of surgical treatment in vitiligo, which is suitable for treating larger areas with better cosmetic results as compared to other grafting methods. The ReCell Autologous Cell Harvesting Device (Avita Medical Europe Limited, Cambridge, UK) is an autologous cell harvesting device which, compared to other forms of autologous epidermal cell suspension grafting, is easier in use showing similar results. Furthermore, the ReCell device needs no laboratory facilities. Therefore, it is promising for patients with large vitiligo and piebaldism lesions.
Objectives: Primary: to asses the efficacy and safety of autologous epidermal cell suspension grafting with the ReCell device after CO2 laser abrasion compared to CO2 laser abrasion alone and no treatment, in patients with piebaldism and stable vitiligo. Secondary: to assess the practical aspects and patients satisfaction of autologous epidermal cell suspension grafting with the ReCell device.
Read more
Study design: Prospective observer blinded randomized controlled pilot study. Study population: 10 patients ≥ 18 years with stable segmental vitiligo or piebaldism who are under treatment at the Netherlands Institute for Pigment Disorders (NIPD) at the Academic Medical Centre University of Amsterdam.
Methods: Three depigmented regions on the trunk or proximal extremities will be randomly allocated to; CO2 laser abrasion + ReCell autologous cell suspension grafting, or CO2 laser abrasion, or no treatment. After the transplantation, UV-treatment according to the standard treatment protocol of the NIPD will be started on all sites and continued for 3 months. Three and six months after grafting, the percentage of repigmentation of the lesions will be assessed.
- Conditions
- Piebaldism, Segmental Vitiligo
- Being tested
- ReCell epidermal cell suspension grafting, CO2 laser abrasion + UV-therapy
- Medical subject headings
- Piebaldism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReCell epidermal cell suspension graftingProcedure or surgery
According to current standard of care procedures the treatment site will be superficially abraded using an ablative laser (10,600nm CO2 laser) after which the prepared ReCell cell suspension will be sprayed on.
CO2 laser abrasion + UV-therapyProcedure or surgery
According to current standard of care procedures the treatment site will be superficially abraded using an ablative laser (10,600nm CO2 laser)
| Study group | Role | What they receive |
|---|---|---|
| ReCell epidermal cell suspension grafting | Experimental | CO2 laser abrasion + ReCell epidermal cell suspension + UV-therapy Receives: Procedure: ReCell epidermal cell suspension grafting |
| CO2 laser abrasion + UV-therapy | Active comparator | According to current standard of care procedures the treatment site will be superficially abraded using an ablative laser (10,600nm CO2 laser) Receives: Procedure: CO2 laser abrasion + UV-therapy |
| No treatment + UV-therapy | No intervention | Not described |
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 6 months after autologous epidermal cell suspension grafting. Assessment will be done by standardized photographs and a digital image analysis system.
Measured: 6 months
Secondary outcomes (2)
Visual assessment of side effects per treatment region
Visual assessment of side effects per treatment region (hyper pigmentation, hypo pigmentation and scar on a scale from 0-3) will be done by a blinded investigator
Measured: 6 months
General outcome assessed by the patient
General outcome will be assessed by the patient per treatment region on a scale from 0-3 (Poor, Moderate, Good, and Excellent)
Measured: 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 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionSep 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PiebaldismStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Komen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640678
- Sponsor's protocol ID
- METC2012_052
- Status last verified
- Aug 2013
- First submitted
- 12 Jul 2012
- Last updated
- 5 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Cell Suspension Grafting Using ReCell in Vitiligo and Piebaldism Patients: a Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT01640678
- Acronym / sponsor ID
- METC2012_052
- Conditions
- Piebaldism, Segmental Vitiligo
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- Jun 2012
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 16 Jul 2012 (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.
Autologous epidermal cell suspension grafting is an effective method of surgical treatment in vitiligo, which is suitable for treating larger areas with better cosmetic results as compared to other grafting methods. The ReCell Autologous Cell Harvesting Device (Avita Medical Europe Limited, Cambridge, UK) is an autologous cell harvesting device which, compared to other forms of autologous epidermal cell suspension grafting, is easier in use showing similar results. Furthermore, the ReCell device needs no laboratory facilities. Therefore, it is promising for patients with large vitiligo and piebaldism lesions.
Objectives: Primary: to asses the efficacy and safety of autologous epidermal cell suspension grafting with the ReCell device after CO2 laser abrasion compared to CO2 laser abrasion alone and no treatment, in patients with piebaldism and stable vitiligo. Secondary: to assess the practical aspects and patients satisfaction of autologous epidermal cell suspension grafting with the ReCell device.
Study design: Prospective observer blinded randomized controlled pilot study. Study population: 10 patients ≥ 18 years with stable segmental vitiligo or piebaldism who are under treatment at the Netherlands Institute for Pigment Disorders (NIPD) at the Academic Medical Centre University of Amsterdam.
Methods: Three depigmented regions on the trunk or proximal extremities will be randomly allocated to; CO2 laser abrasion + ReCell autologous cell suspension grafting, or CO2 laser abrasion, or no treatment. After the transplantation, UV-treatment according to the standard treatment protocol of the NIPD will be started on all sites and continued for 3 months. Three and six months after grafting, the percentage of repigmentation of the lesions will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ReCell epidermal cell suspension grafting | Experimental | Procedure: ReCell epidermal cell suspension graftingCO2 laser abrasion + ReCell epidermal cell suspension + UV-therapy |
| CO2 laser abrasion + UV-therapy | Active comparator | Procedure: CO2 laser abrasion + UV-therapyAccording to current standard of care procedures the treatment site will be superficially abraded using an ablative laser (10,600nm CO2 laser) |
| No treatment + UV-therapy | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patient with piebaldism
- Patients with segmental vitiligo,stable since 12 months without systemic therapy or topical therapy as defined by the absence of new lesions and/or enlargement of existing lesions
- with at least three depigmented skin lesions on the proximal extremities or trunk larger than 3x3 cm or one lesion of at least 9x3 cm
- Age >18
- willing and able to give written informed consent
Key exclusion criteria (13 listed)
- UV therapy or systemic immunosuppressive treatment during the last 12 months
- Local treatment of vitiligo during the last 12 months
- Vitiligo lesions with follicular or non-follicular repigmentation
- Skin type I
- Recurrent HSV skin infections
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 |
|---|---|---|
| ReCell epidermal cell suspension graftingAccording to current standard of care procedures the treatment site will be superficially abraded using an ablative laser (10,600nm CO2 laser) after which the prepared ReCell cell suspension will be sprayed on. | Procedure or surgery | ReCell epidermal cell suspension grafting |
| CO2 laser abrasion + UV-therapyAccording to current standard of care procedures the treatment site will be superficially abraded using an ablative laser (10,600nm CO2 laser) | Procedure or surgery | CO2 laser abrasion + UV-therapy |
Primary outcome
degree of repigmentation
Time frame: 6 months
Objective assessment of the degree of repigmentation 6 months after autologous epidermal cell suspension grafting. Assessment will be done by standardized photographs and a digital image analysis system.
2 secondary outcomes
Visual assessment of side effects per treatment region
Time frame: 6 months
General outcome assessed by the patient
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2013.
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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 Phase 4 study testing ReCell epidermal cell suspension grafting and CO2 laser abrasion + UV-therapy in people with Piebaldism and Segmental Vitiligo, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) 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 5 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: status not confirmed, as of the sponsor's last update on 5 Aug 2013. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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: 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 5 Aug 2013.