NCT00615355

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 2, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 14, 2008

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 12, 2017

Status Verified

January 1, 2017

Enrollment Period

7.8 years

First QC Date

February 2, 2008

Last Update Submit

January 11, 2017

Conditions

Vitiligo

Keywords

vitiligonarrow-band UVBReCelltransplantationlaser

Outcome Measures

Primary Outcomes (1)

  • percentage of repigmentation

    3 and 6 months after transplantation

Secondary Outcomes (1)

  • stability of the achieved repigmentation

    one year after transplantation

Study Arms (2)

Body location

OTHER

Different body locations receive specific treatments

Radiation: UVB 311 nm radiation

Control

ACTIVE COMPARATOR

Treatment with narrow-band UVB

Radiation: UVB 311 nm radiationDevice: UVB 311nm

Interventions

UVB 311 nm radiationRADIATION

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

Also known as: narrow-band UVB
Body locationControl
UVB 311nmDEVICE

Repeated UVB 311nm narrowband irradiation (24 exposures)

Control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • female or male vitiligo patients between the age of 18 and 70
  • Stable vitiligo for at least 1 year

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University, Department of Dermatology

Graz, 8036, Austria

Location

MeSH Terms

Conditions

Vitiligo

Interventions

Radiation

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

  • Angelika Hofer

    Medical Univsersity of Graz, Department of Dermatology, Austria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2008

First Posted

February 14, 2008

Study Start

February 1, 2008

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 12, 2017

Record last verified: 2017-01

Locations

AU(1)