Non-segmental Vitiligo Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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