MedTrace Logo

Punchgrafting Techniques for Vitiligo

NCT01377077 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2011-06-21

No results posted yet for this study

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.

Conditions

  • Non-segmental Vitiligo
  • Segmental Vitiligo
  • Piebaldism

Interventions

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

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01377077 on ClinicalTrials.gov