Punchgrafting Techniques for Vitiligo (MiniSNIP)

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.

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 Overview

• Status: Unknown
• Conditions: Piebaldism; Segmental Vitiligo; Non-segmental Vitiligo
• Intervention / Treatment: Procedure: punchgrafting; Procedure: punchgrafting

• Study Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Phase 4

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
      • Recruiting
      • Netherlands Institute for Pigmentdisorders
      • Contact: Charlotte Vrijman, MD; Phone Number: 0031205662575; Email: c.vrijman@amc.uva.nl
      • Sub-Investigator: Charlotte Vrijman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: epidermal 1mm grafting; Epidermal skin biopsies of 1mm diameter	Procedure: punchgrafting; autologous skin transplantation of small skinbiopsies taken from the hip and replaced in the depigmented lesions; Procedure: punchgrafting; autologous skingrafting of small skin biopsies taken from the hip en placed in the depigmented lesions
EXPERIMENTAL: dermal 1mm grafting; dermal skinbiopsies of 1mm diameter	Procedure: punchgrafting; autologous skin transplantation of small skinbiopsies taken from the hip and replaced in the depigmented lesions; Procedure: punchgrafting; autologous skingrafting of small skin biopsies taken from the hip en placed in the depigmented lesions
EXPERIMENTAL: dermal 1,5mm grafting; dermal skinbiopsies of 1,5mm diameter	Procedure: punchgrafting; autologous skin transplantation of small skinbiopsies taken from the hip and replaced in the depigmented lesions; Procedure: punchgrafting; autologous skingrafting of small skin biopsies taken from the hip en placed in the depigmented lesions
ACTIVE_COMPARATOR: epidermal 1,5mm grafting; epidermal skinbiopsies of 1,5mm diameter	Procedure: punchgrafting; autologous skin transplantation of small skinbiopsies taken from the hip and replaced in the depigmented lesions; Procedure: punchgrafting; autologous skingrafting of small skin biopsies taken from the hip en placed in the depigmented lesions

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (ANTICIPATED): December 1, 2012
• Study Completion (ANTICIPATED): December 1, 2012

Study Registration Dates

• First Submitted: June 17, 2011
• First Submitted That Met QC Criteria: June 20, 2011
• First Posted (ESTIMATE): June 21, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): June 21, 2011
• Last Update Submitted That Met QC Criteria: June 20, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: vitiligo; piebaldism; punchgrafting; minigrafting; stable for at least 12 months
• Additional Relevant MeSH Terms: Metabolic Diseases; Skin Diseases; Genetic Diseases, Inborn; Skin Diseases, Genetic; Eye Diseases, Hereditary; Metabolism, Inborn Errors; Amino Acid Metabolism, Inborn Errors; Pigmentation Disorders; Hypopigmentation; Albinism; Vitiligo; Piebaldism
• Other Study ID Numbers: SNIP punchgrafting study