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

January 11, 2017 updated by: Medical University of Graz

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Medical University, Department of Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Body location
Different body locations receive specific treatments
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
Other Names:
  • narrow-band UVB
Active Comparator: Control
Treatment with narrow-band UVB
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
Other Names:
  • narrow-band UVB
Device: UVB 311nm
Repeated UVB 311nm narrowband irradiation (24 exposures)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
percentage of repigmentation
Time Frame: 3 and 6 months after transplantation
3 and 6 months after transplantation

Secondary Outcome Measures

Outcome Measure
Time Frame
stability of the achieved repigmentation
Time Frame: one year after transplantation
one year after transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Investigators

  • Principal Investigator: Angelika Hofer, Medical Univsersity of Graz, Department of Dermatology, Austria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

February 2, 2008

First Submitted That Met QC Criteria

February 2, 2008

First Posted (Estimate)

February 14, 2008

Study Record Updates

Last Update Posted (Estimate)

January 12, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-262 ex 06/07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vitiligo

Clinical Trials on UVB 311 nm radiation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe