Punchgrafting Techniques for Vitiligo

Study Overview
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Brief Summary
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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.

Official Title
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Autologous Punch Grafting in Vitiligo Patients: the Effect of Punchdepth and Punchsize

Conditions
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Non-segmental Vitiligo, Segmental Vitiligo, Piebaldism

Intervention / Treatment
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* Procedure: punchgrafting
* Procedure: punchgrafting


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: epidermal 1mm grafting<br>Epidermal skin biopsies of 1mm diameter | Procedure: punchgrafting<br>* autologous skin transplantation of small skinbiopsies taken from the hip and replaced in the depigmented lesions<br>Procedure: punchgrafting<br>* autologous skingrafting of small skin biopsies taken from the hip en placed in the depigmented lesions<br>|
| Experimental: dermal 1mm grafting<br>dermal skinbiopsies of 1mm diameter | Procedure: punchgrafting<br>* autologous skin transplantation of small skinbiopsies taken from the hip and replaced in the depigmented lesions<br>Procedure: punchgrafting<br>* autologous skingrafting of small skin biopsies taken from the hip en placed in the depigmented lesions<br>|
| Experimental: dermal 1,5mm grafting<br>dermal skinbiopsies of 1,5mm diameter | Procedure: punchgrafting<br>* autologous skingrafting of small skin biopsies taken from the hip en placed in the depigmented lesions<br>|
| Active Comparator: epidermal 1,5mm grafting<br>epidermal skinbiopsies of 1,5mm diameter | Procedure: punchgrafting<br>* autologous skin transplantation of small skinbiopsies taken from the hip and replaced in the depigmented lesions<br>Procedure: punchgrafting<br>* autologous skingrafting of small skin biopsies taken from the hip en placed in the depigmented lesions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | at 3 and 6 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | at 3 and 6 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitiligo, piebaldism, punchgrafting, minigrafting, stable for at least 12 months