Punchgrafting Techniques for Vitiligo (MiniSNIP)
Primary Purpose
Non-segmental Vitiligo, Segmental Vitiligo, Piebaldism
Status
Unknown status
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
punchgrafting
punchgrafting
Sponsored by
About this trial
This is an interventional treatment trial for Non-segmental Vitiligo focused on measuring vitiligo, piebaldism, punchgrafting, minigrafting, stable for at least 12 months
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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.
Sites / Locations
- Netherlands Institute for PigmentdisordersRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
epidermal 1mm grafting
dermal 1mm grafting
dermal 1,5mm grafting
epidermal 1,5mm grafting
Arm Description
Epidermal skin biopsies of 1mm diameter
dermal skinbiopsies of 1mm diameter
dermal skinbiopsies of 1,5mm diameter
epidermal skinbiopsies of 1,5mm diameter
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01377077
First Posted
June 17, 2011
Last Updated
June 20, 2011
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1. Study Identification
Unique Protocol Identification Number
NCT01377077
Brief Title
Punchgrafting Techniques for Vitiligo
Acronym
MiniSNIP
Official Title
Autologous Punch Grafting in Vitiligo Patients: the Effect of Punchdepth and Punchsize
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-segmental Vitiligo, Segmental Vitiligo, Piebaldism
Keywords
vitiligo, piebaldism, punchgrafting, minigrafting, stable for at least 12 months
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
epidermal 1mm grafting
Arm Type
Experimental
Arm Description
Epidermal skin biopsies of 1mm diameter
Arm Title
dermal 1mm grafting
Arm Type
Experimental
Arm Description
dermal skinbiopsies of 1mm diameter
Arm Title
dermal 1,5mm grafting
Arm Type
Experimental
Arm Description
dermal skinbiopsies of 1,5mm diameter
Arm Title
epidermal 1,5mm grafting
Arm Type
Active Comparator
Arm Description
epidermal skinbiopsies of 1,5mm diameter
Intervention Type
Procedure
Intervention Name(s)
punchgrafting
Intervention Description
autologous skin transplantation of small skinbiopsies taken from the hip and replaced in the depigmented lesions
Intervention Type
Procedure
Intervention Name(s)
punchgrafting
Intervention Description
autologous skingrafting of small skin biopsies taken from the hip en placed in the depigmented lesions
Primary Outcome Measure Information:
Title
Outgrowth of pigment after six months
Description
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.
Time Frame
at 3 and 6 months after treatment
Secondary Outcome Measure Information:
Title
Visual assessment of side effects
Description
Visual assessment of side effects (hyperpigmentation, hypopigmentation, scar, cobble stone effect on a scale from 0-3) by a blinded investigator.
Time Frame
at 3 and 6 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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.
Facility Information:
Facility Name
Netherlands Institute for Pigmentdisorders
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte Vrijman, MD
Phone
0031205662575
Email
c.vrijman@amc.uva.nl
First Name & Middle Initial & Last Name & Degree
Charlotte Vrijman, MD
12. IPD Sharing Statement
Learn more about this trial
Punchgrafting Techniques for Vitiligo
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