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Punchgrafting Techniques for Vitiligo (MiniSNIP)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01377077
First Posted: June 21, 2011
Last Update Posted: June 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
June 17, 2011
June 21, 2011
June 21, 2011
June 2011
December 2012   (Final data collection date for primary outcome measure)
Outgrowth of pigment after six months [ Time Frame: 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.
Same as current
No Changes Posted
Visual assessment of side effects [ Time Frame: 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.
Same as current
Not Provided
Not Provided
 
Punchgrafting Techniques for Vitiligo
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Non-segmental Vitiligo
  • Segmental Vitiligo
  • Piebaldism
  • 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
  • Experimental: epidermal 1mm grafting
    Epidermal skin biopsies of 1mm diameter
    Interventions:
    • Procedure: punchgrafting
    • Procedure: punchgrafting
  • Experimental: dermal 1mm grafting
    dermal skinbiopsies of 1mm diameter
    Interventions:
    • Procedure: punchgrafting
    • Procedure: punchgrafting
  • Experimental: dermal 1,5mm grafting
    dermal skinbiopsies of 1,5mm diameter
    Intervention: Procedure: punchgrafting
  • Active Comparator: epidermal 1,5mm grafting
    epidermal skinbiopsies of 1,5mm diameter
    Interventions:
    • Procedure: punchgrafting
    • Procedure: punchgrafting
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
35
December 2012
December 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT01377077
SNIP punchgrafting study
No
Not Provided
Not Provided
Albert Wolkerstorfer, MD PhD, Netherlands Institute for Pigmentdisorders
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Not Provided
Not Provided
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP