Punchgrafting Techniques for Vitiligo (MiniSNIP)

This study is currently recruiting participants.

Verified June 2011 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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

History of Changes

Tracking Information
First Received Date ^ICMJE	June 17, 2011
Last Updated Date	June 20, 2011
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 ] [ 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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01377077 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 20, 2011)	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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	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	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (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 Arm (s)	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	Recruiting
Estimated Enrollment ^ICMJE	35
Estimated Completion Date	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Netherlands

Administrative Information
NCT Number ^ICMJE	NCT01377077
Other Study ID Numbers ^ICMJE	SNIP punchgrafting study
Has Data Monitoring Committee	No
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
Information Provided By	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

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