Epidermal Cell Transplantation in Vitiligo Skin With and Without Narrow-Band UVB Treatment - Full Text View

Sponsored by:	Medical University of Graz
Information provided by:	Medical University of Graz
ClinicalTrials.gov Identifier:	NCT00615355

Purpose

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

Condition	Intervention
Vitiligo	Radiation: UVB 311nm radiation

MedlinePlus related topics: Vitiligo

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Dose Comparison, Single Group Assignment, Efficacy Study
Official Title:	Efficacy of Narrow-Band UVB Treatment After Transplantation of Harvested Epidermal Cells in Vitiligo

Further study details as provided by Medical University of Graz:

Primary Outcome Measures:

percentage of repigmentation [ Time Frame: 3 and 6 months after transplantation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

stability of the achieved repigmentation [ Time Frame: one year after transplantation ] [ Designated as safety issue: No ]

Estimated Enrollment:	11
Study Start Date:	February 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
body location Different body locations receive specific treatments	Radiation: UVB 311nm radiation UVB 311nm 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

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 too 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 week 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 30mJ/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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615355

Contacts

Contact: Angelika Hofer, MD	+43/216-385 ext 3254	angelika.hofer@meduni-graz.at
Contact: Peter Wolf, MD	+43/216-385 ext 3254	peter.wolf@meduni-graz.at

Locations

Austria
Medical University, Department of Dermatology	Recruiting
Graz, Austria, 8036
Contact: Angelika Hofer +43/316-385-2423 angelika.hofer@meduni-graz.at
Contact: Peter Wolf +43/316-385-2423 peter.wolf@meduni-graz.at
Sub-Investigator: Michael Horn, MD
Sub-Investigator: Franz f Legat, MD
Sub-Investigator: Daisy Kopera, MD
Sub-Investigator: Peter Wolf, MD

Sponsors and Collaborators

Medical University of Graz

Investigators

Principal Investigator:

Angelika Hofer

Medical Univsersity of Graz, Department of Dermatology, Austria

More Information

Responsible Party:	Medical University of Graz ( Angelika Hofer, MD )
Study ID Numbers:	18-262 ex 06/07
Study First Received:	February 2, 2008
Last Updated:	December 31, 2008
ClinicalTrials.gov Identifier:	NCT00615355
Health Authority:	Austria: Federal Ministry for Health and Women

Keywords provided by Medical University of Graz:

vitiligo, narrow-band UVB, ReCell, transplantation, laser

Study placed in the following topic categories:

Hypopigmentation
Skin Diseases
Pigmentation Disorders
Hypomelanotic disorder
Vitiligo

ClinicalTrials.gov processed this record on January 14, 2009