Trial record 20 of 55 for:    "vitiligo"

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT00615355
First received: February 2, 2008
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention
Vitiligo
Radiation: UVB 311 nm radiation
Device: UVB 311nm

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Narrow-band UVB Treatment After Transplantation of Harvested Epidermal Cells in Vitiligo

Resource links provided by NLM:


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: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: narrow-band UVB
Device: UVB 311nm
Repeated UVB 311nm narrowband irradiation (24 exposures)

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Austria
Medical University, Department of Dermatology
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Angelika Hofer Medical Univsersity of Graz, Department of Dermatology, Austria
  More Information

No publications provided

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT00615355     History of Changes
Other Study ID Numbers: 18-262 ex 06/07
Study First Received: February 2, 2008
Last Updated: July 22, 2014
Health Authority: Austria: Federal Ministry for Health and Women

Keywords provided by Medical University of Graz:
vitiligo
narrow-band UVB
ReCell
transplantation
laser

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases

ClinicalTrials.gov processed this record on October 01, 2014