Epidermal Cell Transplantation in Vitiligo Skin With and Without Narrow-band Ultraviolet B (UVB) Treatment
Condition: Vitiligo
MeSH terms: Vitiligo
Study type: Interventional

Summary: 
      The effect of treatment with narrow-band UVB 311 nm after transplantation of harvested
      autologous epidermal cells on vitiligo lesions will be investigated.
    

Detailed description: 
      Introduction: Surgical interventions in vitiligo are widely used and additional UV exposure
      is often recommended after successful transplantation. However, little is known about the
      additional efficacy of (narrow-band) UVB due to missing comparative studies.

      Aim of the study: To perform a prospective, controlled, randomized, intra-individual
      comparative study in vitiligo lesions treated with epidermal cell transplantation using the
      ReCell method with and without additional narrow-band UVB treatment.

      Study design: Two weeks after transplantation of epidermal cells, one randomly chosen half of
      the transplanted patch will be additionally treated with narrow-band UVB therapy whereas the
      other half will be left untreated. For control purpose, 2 additional patches (or the two
      halfs of one patch) will be selected to be treated with either laser dermabrasion and
      narrow-band UVB or narrow-band UVB treatment alone.

      Grafting with the ReCell method: A superficial skin shaving excision of 2 x 2 cm will be
      obtained from pigmented skin (UVA irradiation 4 weeks before the excision) using a Silver
      knife. A cell suspension will be obtained using the ReCell transplantation kit, according to
      the instructions of the manufactures. The vitiligo skin will be dermabraded by Erbium: Yag
      laser after local anaesthesia. Thereafter the cell suspension will be sprayed on the
      dermabraded skin area and fixed with special wound dressings.

      Narrow-band UVB treatment: The initial UVB dose will be 50% of the minimal erythema dose,
      tested next to the vitiligo lesions to be treated. Treatment will be performed 2 times a week
      with a targeted UVB device (Dualight, TheraLight). Dose increments will be 30 mJ/cm2 at each
      treatment up to a dose that induces slight erythema longer than 24 hours. If this dose is
      reached, the dose will be reduced to the last well tolerated dose and no further increments
      will follow. Narrow-band UVB treatment will be performed for at least 3 months or 24
      treatments.

      Evaluation of the treatment success: The grade of pigmentation in all lesions will be
      evaluated clinically, with photographs and with laser scanning microscope every 3 weeks
      during the first 3 months of the study and later every 3 months within the first year. The
      clinical rating will be performed as follows: 0 = no repigmentation; 1 = 1-25%
      repigmentation; 2 = 26 to 50% repigmentation; 3 = 51 to 75% repigmentation; and 4 = 76 to
      100% repigmentation. The evaluation of the photographs and the laser scanning microscopy
      pictures will be performed blinded by physicians not engaged in the treatment phase of the
      study.
    

Intervention name(s): UVB 311 nm radiation; UVB 311nm
Intervention type(s): Radiation; Device
Intervention description(s): UVB 311 nm radiation randomized to one half of the transplanted vitiligo lesion given 2 times a week for 3 months; the other half of the transplanted lesion remains UV-non-irradiated; Repeated UVB 311nm narrowband irradiation (24 exposures)
Other intervention name(s): narrow-band UVB
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: vitiligo; narrow-band UVB; ReCell; transplantation; laser