Epidermal Cell Transplantation in Vitiligo Skin With and Without Narrow-band Ultraviolet B (UVB) Treatment

Vitiligo Clinical Trial

Official title:

Efficacy of Narrow-band UVB Treatment After Transplantation of Harvested Epidermal Cells in Vitiligo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00615355
• Other study ID #: 18-262 ex 06/07
• Status: Completed
• Phase: N/A
• First received: February 2, 2008
• Last updated: January 11, 2017
• Start date: February 2008
• Est. completion date: December 2015

Study information

• Verified date: January 2017
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 11 female or male vitiligo patients between the age of 18 and 70

• Stable vitiligo for at least 1 year

Exclusion Criteria:

• Progressive disease within the last 12 months

• Sporadic repigmentation of single patches within the last 12 months

• Patients with contraindications for UV-treatment

• Patients with anticoagulant treatment, bleeding disorders

• Patients with prolonged wound healing in the history

• History of hypertrophic scarring or keloids or Köbner phenomenon

• Reduced general health status

• Patients with allergic reactions to local anaesthesia

• Topical steroids or calcineurin inhibitors in the last 4 weeks before study entry

• UV exposure in the last 4 weeks before study entry

• Pregnancy or lactation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vitiligo

Intervention

Radiation:
• UVB 311 nm radiation
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

Device:
• UVB 311nm
Repeated UVB 311nm narrowband irradiation (24 exposures)

Locations

Country	Name	City	State
Austria	Medical University, Department of Dermatology	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of repigmentation		3 and 6 months after transplantation	No
Secondary	stability of the achieved repigmentation		one year after transplantation	No