Non-segmental VitiligoPhase 4MiniSNIPNCT01377077
Punchgrafting Techniques for Vitiligo
A Phase 4 study testing punchgrafting in people with Non-segmental Vitiligo and Segmental Vitiligo, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Rationale: Punch grafting is a safe, simple and widely used technique for in vitiligo. However, no reliable data are available on the effect of punch depth and punch size. Objectives: Primary: to compare the efficacy and safety of different punchdepths and punchsizes in punch grafting in patients with segmental and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-segmental Vitiligo, Segmental Vitiligo, Piebaldism
- What is being tested?
- punchgrafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2011to Dec 2012
- 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
- Patients with non-segmental and segmental vitiligo under medical treatment at the Netherlands Institute for Pigment Disorders
- Age between 18 and 60 years
- Patient is willing and able to give written informed consent
- Vitiligo stable since 12 months without systemic therapy or 6 months without topical therapy as defined by the absence of new lesions and/or enlargement of existing lesions.
- Vitiligo lesions on the extremities or trunk larger than 5x5cm
Who cannot join
- UV therapy or systemic immunosuppressive treatment during the last 12 months
- Local treatment of vitiligo during the last 6 months
- Vitiligo lesions with folliculair or non-folliculair repigmentations
- Skin type 1
- Hypertrophic scars
- Keloid
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- Cardial insufficiency
- Patients with a history of hypersensitivity to (UVB) light and allergy to local anesthesia.
- Patients who are pregnant or breast-feeding
- Patients not competent to understand what the procedures involved
- Patients with a personal history of melanoma or non-melanoma skin cancer
- Patients with a first degree relative with melanoma skin cancer
- Patients with atypical nevi.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Netherlands Institute for Pigmentdisorders
Amsterdam, North Holland, 1105 AZ
Charlotte Vrijman, MD, 0031205662575, c.vrijman@amc.uva.nl
Charlotte Vrijman, MD
About this study
Official title: Autologous Punch Grafting in Vitiligo Patients: the Effect of Punchdepth and Punchsize
Rationale: Punch grafting is a safe, simple and widely used technique for in vitiligo. However, no reliable data are available on the effect of punch depth and punch size.
Objectives: Primary: to compare the efficacy and safety of different punchdepths and punchsizes in punch grafting in patients with segmental and non-segmental vitiligo. Secondary: to assess the practical aspects and patients preference of different punch grafting techniques.
Read more
Study design: Prospective observer blinded randomised controlled study. Study population: 35 patients ≥ 18 years with segmental or stable non-segmental vitiligo who will receive regular treatment by punch grafting at the Netherlands Institute for Pigment Disorders (SNIP) at the Academic Medical Centre University of Amsterdam.
Methods: Four depigmented regions on the trunk or upper extremities will be randomly allocated to either epidermal 1,5 mm punch grafting, epidermal 1mm punch grafting, dermal 1,5 mm punch grafting and dermal 1 mm punch grafting. After grafting, all regions will receive UV-therapy twice a week for 3 months. Three and six months after grafting, the repigmentation of the lesions will be assessed by measuring the outgrowth.
Main study parameter/endpoint: Outgrowth of pigment after six months.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The study involves 16 additional punch grafts but no additional visits to our institute. Patients will not miss any regular treatment. The extra time due to participation in the study will be about 40 minutes. No increase of the risk of side effects is expected by placing 16 additional punch grafts. 1.
- Conditions
- Non-segmental Vitiligo, Segmental Vitiligo, Piebaldism
- Being tested
- punchgrafting
- Keywords
- vitiligo, piebaldism, punchgrafting, minigrafting, stable for at least 12 months
- Medical subject headings
- Piebaldism, Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
punchgraftingProcedure or surgery
autologous skin transplantation of small skinbiopsies taken from the hip and replaced in the depigmented lesions
punchgraftingProcedure or surgery
autologous skingrafting of small skin biopsies taken from the hip en placed in the depigmented lesions
| Study group | Role | What they receive |
|---|---|---|
| epidermal 1mm grafting | Experimental | Epidermal skin biopsies of 1mm diameter Receives: Procedure: punchgrafting |
| dermal 1mm grafting | Experimental | dermal skinbiopsies of 1mm diameter Receives: Procedure: punchgrafting |
| dermal 1,5mm grafting | Experimental | dermal skinbiopsies of 1,5mm diameter Receives: Procedure: punchgrafting |
| epidermal 1,5mm grafting | Active comparator | epidermal skinbiopsies of 1,5mm diameter Receives: Procedure: punchgrafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outgrowth of pigment after six months
Objective assessment of the repigmentation 3 and 6 months after punch grafting. Assessment will be done using a ruler on a dermatoscope to measure the diameter of the growth of the punchgrafts. The surface of repigmentation will be calculated.
Measured: at 3 and 6 months after treatment
Secondary outcomes (1)
Visual assessment of side effects
Visual assessment of side effects (hyperpigmentation, hypopigmentation, scar, cobble stone effect on a scale from 0-3) by a blinded investigator.
Measured: at 3 and 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01377077
- Sponsor's protocol ID
- SNIP punchgrafting study
- Acronym
- MiniSNIP
- Status last verified
- Jun 2011
- First submitted
- 17 Jun 2011
- Last updated
- 21 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Punch Grafting in Vitiligo Patients: the Effect of Punchdepth and Punchsize
- ClinicalTrials.gov ID
- NCT01377077
- Acronym / sponsor ID
- MiniSNIP / SNIP punchgrafting study
- Conditions
- Non-segmental Vitiligo, Segmental Vitiligo, Piebaldism
- Keywords
- vitiligo, piebaldism, punchgrafting, minigrafting, stable for at least 12 months
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- Jun 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 21 Jun 2011 (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: Punch grafting is a safe, simple and widely used technique for in vitiligo. However, no reliable data are available on the effect of punch depth and punch size.
Objectives: Primary: to compare the efficacy and safety of different punchdepths and punchsizes in punch grafting in patients with segmental and non-segmental vitiligo. Secondary: to assess the practical aspects and patients preference of different punch grafting techniques.
Study design: Prospective observer blinded randomised controlled study. Study population: 35 patients ≥ 18 years with segmental or stable non-segmental vitiligo who will receive regular treatment by punch grafting at the Netherlands Institute for Pigment Disorders (SNIP) at the Academic Medical Centre University of Amsterdam.
Methods: Four depigmented regions on the trunk or upper extremities will be randomly allocated to either epidermal 1,5 mm punch grafting, epidermal 1mm punch grafting, dermal 1,5 mm punch grafting and dermal 1 mm punch grafting. After grafting, all regions will receive UV-therapy twice a week for 3 months. Three and six months after grafting, the repigmentation of the lesions will be assessed by measuring the outgrowth.
Main study parameter/endpoint: Outgrowth of pigment after six months.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The study involves 16 additional punch grafts but no additional visits to our institute. Patients will not miss any regular treatment. The extra time due to participation in the study will be about 40 minutes. No increase of the risk of side effects is expected by placing 16 additional punch grafts. 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| epidermal 1mm grafting | Experimental | Procedure: punchgraftingEpidermal skin biopsies of 1mm diameter |
| dermal 1mm grafting | Experimental | Procedure: punchgraftingdermal skinbiopsies of 1mm diameter |
| dermal 1,5mm grafting | Experimental | Procedure: punchgraftingdermal skinbiopsies of 1,5mm diameter |
| epidermal 1,5mm grafting | Active comparator | Procedure: punchgraftingepidermal skinbiopsies of 1,5mm diameter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with non-segmental and segmental vitiligo under medical treatment at the Netherlands Institute for Pigment Disorders
- Age between 18 and 60 years
- Patient is willing and able to give written informed consent
- Vitiligo stable since 12 months without systemic therapy or 6 months without topical therapy as defined by the absence of new lesions and/or enlargement of existing lesions.
- Vitiligo lesions on the extremities or trunk larger than 5x5cm
Key exclusion criteria (13 listed)
- UV therapy or systemic immunosuppressive treatment during the last 12 months
- Local treatment of vitiligo during the last 6 months
- Vitiligo lesions with folliculair or non-folliculair repigmentations
- Skin type 1
- Hypertrophic scars
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 |
|---|---|---|
| punchgraftingautologous skin transplantation of small skinbiopsies taken from the hip and replaced in the depigmented lesions | Procedure or surgery | dermal 1mm grafting, epidermal 1,5mm grafting, epidermal 1mm grafting |
| punchgraftingautologous skingrafting of small skin biopsies taken from the hip en placed in the depigmented lesions | Procedure or surgery | dermal 1,5mm grafting, dermal 1mm grafting, epidermal 1,5mm grafting, epidermal 1mm grafting |
Primary outcome
Outgrowth of pigment after six months
Time frame: at 3 and 6 months after treatment
Objective assessment of the repigmentation 3 and 6 months after punch grafting. Assessment will be done using a ruler on a dermatoscope to measure the diameter of the growth of the punchgrafts. The surface of repigmentation will be calculated.
1 secondary outcome
Visual assessment of side effects
Time frame: at 3 and 6 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2011.
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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.
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 punchgrafting in people with Non-segmental Vitiligo 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 21 Jun 2011. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outgrowth of pigment after six months (time frame: at 3 and 6 months after treatment). 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 21 Jun 2011.