leucoderma
Conditions
Interventions
In each patient three (parts of) depigmented lesion(s) are randomly allocated
to receive one of the following regimes:
1) CO2 laser abrasion + ReCell epidermal skin graft suspension + UV-therapy
2)
Sponsors
Stichting Nederlands Instituut voor Pigmentstoornissen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients with segmental vitiligo or piebaldism under medical treatment at the Netherlands Institute for Pigment Disorders Age >18 Patient is willing and able to give written informed consent Segmental 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. At least three vitiligo lesions on the proximal extremities or trunk larger than 3x3 cm or one vitiligo
Exclusion criteria
Exclusion criteria: UV therapy or systemic immunosuppressive treatment during the last 12 months Local treatment of vitiligo during the last 12 months Vitiligo lesions with folliculair or non-folliculair repigmentations Skin type I and II Recurrent HSV skin infections Hypertrophic scars Keloid Cardial insufficiency Patients with a history of hypersensitivity to (UVB or UVA) light and/or 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameter/endpoint: * Objective assessment of the degree of repigmentation 6 months after autologous epidermal cell suspension grafting. Assessment will be done by standardized (UVA) photographs and a digital image analysis system. A Canon G6 is used under standardized circumstances (camera setting, distance and UVA flash) to obtain digital images before and after treatment. Software based on Matlab will be used to analyse the images and to calculate the depigmented surface. By comparing pre- and post treatment images, the surface showing repigmentation can be computed. * Visual assessment of side effects per treatment region (hyper pigmentation, hypo pigmentation and scar on a scale from 0-3) will be done by a blinded investigator. * General outcome will be assessed by the patient per treatment region on a scale from 0-3 (Poor, Moderate, Good, and Excellent). | — |
Secondary
| Measure | Time frame |
|---|---|
| * The superfluous of the suspension will be used for cellular analyses, to investigate the density of viable melanocytes, keratinocytes, stemcells, viable melanocytes and keratinocytes in the cell suspension. * Adverse events of the procedure will be documented | — |
Countries
Netherlands
Outcome results
None listed