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Punchgrafting Techniques for Vitiligo (MiniSNIP)

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ClinicalTrials.gov Identifier: NCT01377077
Recruitment Status : Unknown
Verified June 2011 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Recruitment status was:  Recruiting
First Posted : June 21, 2011
Last Update Posted : June 21, 2011
Sponsor:
Information provided by:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Tracking Information
First Submitted Date  ICMJE June 17, 2011
First Posted Date  ICMJE June 21, 2011
Last Update Posted Date June 21, 2011
Study Start Date  ICMJE June 2011
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2011)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Punchgrafting Techniques for Vitiligo
Official Title  ICMJE Autologous Punch Grafting in Vitiligo Patients: the Effect of Punchdepth and Punchsize
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Non-segmental Vitiligo
  • Segmental Vitiligo
  • Piebaldism
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 20, 2011)
35
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2012
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01377077
Other Study ID Numbers  ICMJE SNIP punchgrafting study
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Albert Wolkerstorfer, MD PhD, Netherlands Institute for Pigmentdisorders
Study Sponsor  ICMJE Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Verification Date June 2011

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