Punchgrafting Techniques for Vitiligo (MiniSNIP)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status and phase: Unknown; Phase 4

Conditions: Piebaldism; Segmental Vitiligo; Non-segmental Vitiligo

Treatments: Procedure: punchgrafting

Study type: Interventional

Funder types: Other

Identifiers

NCT01377077

SNIP punchgrafting study

Details and patient eligibility

About

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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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35 participants in 4 patient groups

epidermal 1mm grafting

Experimental group

Description:

Epidermal skin biopsies of 1mm diameter

Treatment:

Procedure: punchgrafting

Procedure: punchgrafting

dermal 1mm grafting

Experimental group

Description:

dermal skinbiopsies of 1mm diameter

Treatment:

Procedure: punchgrafting

Procedure: punchgrafting

dermal 1,5mm grafting

Experimental group

Description:

dermal skinbiopsies of 1,5mm diameter

Treatment:

Procedure: punchgrafting

Procedure: punchgrafting

epidermal 1,5mm grafting

Active Comparator group

Description:

epidermal skinbiopsies of 1,5mm diameter

Treatment:

Procedure: punchgrafting

Procedure: punchgrafting