Epidermal Cell Transplantation in Vitiligo Skin
Condition: VITILIGO
MeSH terms: Vitiligo
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The effects of treatment of transplantation of harvested autologous epidermal cells on
      vitiligo lesions followed by narrow-band UVB will be investigated in a randomized controlled
      study.
    

Detailed description: 
      Introduction: Transplantation of harvested autologous epidermal cells in vitiligo is widely
      used in vitiligo but randomized controlled trials in the literature investigating the
      efficacy of these noncultured keratinocyte/melanocyte suspensions are scarce. In addition
      there are few data regarding the relationship between the cellular contents of epidermal
      suspensions and the clinical outcome.

      Aim of the study: To perform a prospective, controlled, randomized, intra-individual
      comparative study in vitiligo lesions treated with epidermal cell transplantation with
      additional narrow-band UVB treatment using epidermal cell suspensions that have been
      characterized at the cellular level.

      Study design:

      Grafting with epidermal cells: A superficial skin shaving excision will be obtained from
      pigmented skin using a dermatome. A cell suspension will be obtained by trypsinisation.
      Vitiligo skin will be dermabraded by Erbium: Yag laser after local anaesthesia. The cell
      suspension will be spread on the dermabraded skin area and fixed with dressings.
      Keratinocyte, and melanocyte counts will be performed on an aliquot of the cell suspension.
      One symmetrical patch of vitiligo will be chosen as control and left untreated.

      Narrow-band UVB treatment: Four weeks after transplantation of epidermal cells, the grafted
      and control patch will be treated by Narrow-band UVB. Treatment will be performed 2 times a
      week. 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. 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 will be
      performed blinded by physicians not engaged in the treatment phase of the study. In addition
      the surface of vitiligo patches will be traced on transparent sheets and monitored by
      planimetry.
    

Intervention name(s): Grafting with epidermal cells; UVB treatment
Intervention type(s): Procedure; Radiation
Intervention description(s): A superficial skin shaving excision will be obtained from pigmented skin using a dermatome. A cell suspension will be obtained by trypsinisation. Vitiligo skin will be dermabraded by Erbium: Yag laser after local anaesthesia. The cell suspension will be spread on the dermabraded skin area and fixed with dressings. Keratinocyte, and melanocyte counts will be performed on an aliquot of the cell suspension. One symmetrical patch of vitiligo will be chosen as control and left untreated.
Narrow-band UVB treatment: Four weeks after transplantation of epidermal cells, the grafted and control patch will be treated by Narrow-band UVB. Treatment will be performed 2 times a week. Narrow-band UVB treatment will be performed for at least 3 months or 24 treatments.; the control patch will be treated by Narrow-band UVB. Treatment will be performed 2 times a week. Narrow-band UVB treatment will be performed for at least 3 months or 24 treatments.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment