Punchgrafting Techniques for Vitiligo

Non-segmental Vitiligo Clinical Trial

— MiniSNIP  

Official title:

Autologous Punch Grafting in Vitiligo Patients: the Effect of Punchdepth and Punchsize

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01377077
• Other study ID #: SNIP punchgrafting study
• Status: Recruiting
• Phase: Phase 4
• First received: June 17, 2011
• Last updated: June 20, 2011
• Start date: June 2011
• Est. completion date: December 2012

Study information

• Verified date: June 2011
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Netherlands Institute for Pigmentdisorders, Academic Medical Center
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Non-segmental Vitiligo
• Piebaldism
• Segmental Vitiligo
• Vitiligo

Intervention

Procedure:
• punchgrafting
autologous skin transplantation of small skinbiopsies taken from the hip and replaced in the depigmented lesions
• punchgrafting
autologous skingrafting of small skin biopsies taken from the hip en placed in the depigmented lesions

Locations

Country	Name	City	State
Netherlands	Netherlands Institute for Pigmentdisorders	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outgrowth of pigment after six months	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.	at 3 and 6 months after treatment	No
Secondary	Visual assessment of side effects	Visual assessment of side effects (hyperpigmentation, hypopigmentation, scar, cobble stone effect on a scale from 0-3) by a blinded investigator.	at 3 and 6 months after treatment	Yes