Punchgrafting Techniques for Vitiligo

Phase 4

• Conditions: Non-segmental Vitiligo; Segmental Vitiligo; Piebaldism
• Interventions: Procedure: punchgrafting

• Registration Number: NCT01377077
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-06
• Study Start: 2011-06
• Study First Submitted: 2011-06-17
• Study First Submitted QC: 2011-06-20
• Last Update Submitted: 2011-06-20
• Study First Posted: 2011-06-21
• Last Update Posted: 2011-06-21
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
dermal 1,5mm grafting	punchgrafting	dermal skinbiopsies of 1,5mm diameter
epidermal 1mm grafting	punchgrafting	Epidermal skin biopsies of 1mm diameter
dermal 1mm grafting	punchgrafting	dermal skinbiopsies of 1mm diameter
epidermal 1,5mm grafting	punchgrafting	epidermal skinbiopsies of 1,5mm diameter

Primary Outcome Measures

Name	Time	Method
Outgrowth of pigment after six months	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.

Secondary Outcome Measures

Name	Time	Method
Visual assessment of side effects	at 3 and 6 months after treatment	Visual assessment of side effects (hyperpigmentation, hypopigmentation, scar, cobble stone effect on a scale from 0-3) by a blinded investigator.

Trial Locations

Locations (1)

Netherlands Institute for Pigmentdisorders; 🇳🇱 Amsterdam, Noord-Holland, Netherlands