Trial record 1 of 55 for:    "Vitiligo"
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Punchgrafting Techniques for Vitiligo (MiniSNIP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT01377077
First received: June 17, 2011
Last updated: June 20, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Non-segmental Vitiligo
Segmental Vitiligo
Piebaldism
Procedure: punchgrafting
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Autologous Punch Grafting in Vitiligo Patients: the Effect of Punchdepth and Punchsize

Resource links provided by NLM:


Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • Outgrowth of pigment after six months [ Time Frame: at 3 and 6 months after treatment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Visual assessment of side effects [ Time Frame: at 3 and 6 months after treatment ] [ Designated as safety issue: Yes ]
    Visual assessment of side effects (hyperpigmentation, hypopigmentation, scar, cobble stone effect on a scale from 0-3) by a blinded investigator.


Estimated Enrollment: 35
Study Start Date: June 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: epidermal 1mm grafting
Epidermal skin biopsies of 1mm diameter
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: dermal 1mm grafting
dermal skinbiopsies of 1mm diameter
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: dermal 1,5mm grafting
dermal skinbiopsies of 1,5mm diameter
Procedure: punchgrafting
autologous skingrafting of small skin biopsies taken from the hip en placed in the depigmented lesions
Active Comparator: epidermal 1,5mm grafting
epidermal skinbiopsies of 1,5mm diameter
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01377077

Locations
Netherlands
Netherlands Institute for Pigmentdisorders Recruiting
Amsterdam, Noord-Holland, Netherlands, 1105 AZ
Contact: Charlotte Vrijman, MD    0031205662575    c.vrijman@amc.uva.nl   
Sub-Investigator: Charlotte Vrijman, MD         
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  More Information

No publications provided

Responsible Party: Albert Wolkerstorfer, MD PhD, Netherlands Institute for Pigmentdisorders
ClinicalTrials.gov Identifier: NCT01377077     History of Changes
Other Study ID Numbers: SNIP punchgrafting study
Study First Received: June 17, 2011
Last Updated: June 20, 2011
Health Authority: Netherlands: Netherlands Institute for Pigmentdisorders, Academic Medical Center

Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
vitiligo
piebaldism
punchgrafting
minigrafting
stable for at least 12 months

Additional relevant MeSH terms:
Vitiligo
Piebaldism
Albinism
Amino Acid Metabolism, Inborn Errors
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Hypopigmentation
Metabolic Diseases
Metabolism, Inborn Errors
Pigmentation Disorders
Skin Diseases
Skin Diseases, Genetic

ClinicalTrials.gov processed this record on October 23, 2014