VITILIGO Clinical Trial
Official title:
Efficacy and Tolerance of Transplantation of Harvested Epidermal Cells and Narrow-Band UVB in Vitiligo
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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