Autologous Cell Suspension Grafting Using ReCell in Vitiligo and Piebaldism Patients
Segmental Vitiligo, Piebaldism
About this trial
This is an interventional treatment trial for Segmental Vitiligo focused on measuring Ablative laser, Fractional laser, Vitiligo, Piebaldism, Cell suspension grafting
Eligibility 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:
- 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
- Cardiac 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 involves
- Patients with a personal history of melanoma or non-melanoma skin cancer
- Patients with atypical nevi.
- Known allergy to clarithromycin
Sites / Locations
- Netherlands Institute for Pigment disorders
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Experimental
Experimental
No Intervention
Full surface CO2 laser 200mJ + ReCell
Full surface CO2 laser 150mJ + ReCell
Fractional CO2 laser 7.5mJ 20% + ReCell
Control
This test region will receive full surface pretreatment with the CO2 laser (Ultrapulse, ActiveFX handpiece, Lumenis Inc., Santa Clara, CA, USA) at 200 mJ (depth 209 µm) and density 3. After pretreatment ReCell autologous epidermal cell suspension will be applied on this test region.
This test region will receive full surface pretreatment with the CO2 laser (Ultrapulse, ActiveFX handpiece, Lumenis Inc., Santa Clara, CA, USA) at 150 mJ (depth 144 µm) and density 3. After pretreatment ReCell autologous epidermal cell suspension will be applied on this test region.
This test region will receive pretreatment with the fractional CO2 laser (Ultrapulse, DeepFX handpiece, Lumenis Inc., Santa Clara, CA, USA) at 7.5 mJ/microbeam (depth 225 µm) and 20% density. After pretreatment ReCell autologous epidermal cell suspension will be applied on this test region.
No intervention