piebaldism segmental vitiligo
Conditions
Interventions
Four depigmented regions on the trunk or extremities will be randomly allocated
to:
I CO2 ActiveFx 200 mJ 60 W density 3 (full surface ablation, depth 209 µm) +
ReCell epidermal skin graft suspensi
Sponsors
Academisch Medisch Centrum
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 12 months without topical therapy as defined by the absence of new lesions and/or enlargement of existing lesions. At least four depigmented lesions on the proximal extremities or trunk larger than 3x3 cm or one depigmented lesion on the proximal extremities or trunk of at least 12x3 cm
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 follicular or non-follicular repigmentations Skin type I 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 anaesthesia. 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 atypical nevi Known allergy to clarithromycin
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| -Blinded physician*s assessment of repigmentation using standardized photographs. -General patient assessed outcome per treatment region on a scale from 0-3 (poor, moderate, good or excellent). -Visual assessment of side effects per treatment region (hyperpigmentation, hypopigmentation and scarring on a scale from 0-3) by a blinded investigator. -The superfluous of the suspension will be used for cellular analyses, to investigate the density of melanocytes, keratinocytes, stem cells, viable melanocytes and keratinocytes in the cell suspension. | — |
Primary
| Measure | Time frame |
|---|---|
| Objective assessment of the degree of repigmentation six months after autologous epidermal cell suspension grafting with a digital image analysing system. | — |
Countries
Netherlands
Outcome results
None listed