Clinical trial NCT01377077: Punchgrafting Techniques for Vitiligo
Official title: Autologous Punch Grafting in Vitiligo Patients: the Effect of Punchdepth and Punchsize
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Non-segmental Vitiligo
Segmental Vitiligo
Piebaldism
Keywords: vitiligo
piebaldism
punchgrafting
minigrafting
stable for at least 12 months
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2011-06-21
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Outgrowth of pigment after six months
timeFrame: at 3 and 6 months after treatment
Secondary outcomes:
measure: Visual assessment of side effects
timeFrame: at 3 and 6 months after treatment
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Netherlands Institute for Pigmentdisorders
state: Noord-Holland
Study officials:
References: