Punchgrafting Techniques for Vitiligo

NCT01377077 | Unknown Phase 4

• 1 other identifier: SNIP punchgrafting study
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-segmental Vitiligo; Segmental Vitiligo; Piebaldism

Keywords

vitiligo; piebaldism; punchgrafting; minigrafting; stable for at least 12 months

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Visual assessment of side effects

  at 3 and 6 months after treatment

Study Arms (4)

epidermal 1mm grafting

EXPERIMENTAL

Epidermal skin biopsies of 1mm diameter

Procedure: punchgrafting

dermal 1mm grafting

EXPERIMENTAL

dermal skinbiopsies of 1mm diameter

Procedure: punchgrafting

dermal 1,5mm grafting

EXPERIMENTAL

dermal skinbiopsies of 1,5mm diameter

Procedure: punchgrafting

epidermal 1,5mm grafting

ACTIVE COMPARATOR

epidermal skinbiopsies of 1,5mm diameter

Procedure: punchgrafting

Interventions

punchgrafting PROCEDURE

autologous skin transplantation of small skinbiopsies taken from the hip and replaced in the depigmented lesions

dermal 1mm grafting; epidermal 1,5mm grafting; epidermal 1mm grafting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Netherlands Institute for Pigmentdisorders

Amsterdam, North Holland, 1105 AZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Piebaldism; Vitiligo

Condition Hierarchy (Ancestors)

Albinism; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Skin Diseases, Genetic; Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 17, 2011
• First Posted: June 21, 2011
• Study Start: June 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 21, 2011

Record last verified: 2011-06

Locations

NL (1)