NCT00398723

Brief Summary

The study offers narrowband UVB light therapy to patients who have 5% of their body involved with vitiligo. The hypothesis is that Narrowband UVB promotes melanocyte proliferation in vitiligo lesions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2006

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 14, 2006

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

October 13, 2011

Status Verified

October 1, 2011

Enrollment Period

1 year

First QC Date

November 10, 2006

Last Update Submit

October 11, 2011

Conditions

Vitiligo

Keywords

Narrowband UBV PhototherapySkin biopsies

Outcome Measures

Primary Outcomes (1)

  • Number of melanocytes per unit length of skin surface

    pre-treatment, early repigmentation, 75% repigmentation of total body

Secondary Outcomes (1)

  • Clinical improvement

    first visit and last visit

Study Arms (1)

Vitiligo

EXPERIMENTAL

adult patients (age 18 or greater) with extensive vitiligo warranting treatment with whole body NB-UVB

Device: Narrowband UVB

Interventions

Narrowband UVBDEVICE

Treatment three to seven times weekly for a total of 12 to 26 weeks (36 to 168 treatments). Dosing of NB-UVB will begin at 100-280 mJ/cm2, depending on tolerance and skin type, and will be titrated 10-20% per session until clinical efficacy or symptomatic erythema

Vitiligo

Eligibility Criteria

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

You may qualify if:

  • Age 18 years of age or greater
  • Vitiligo with extensive skin involvement (\>5% body surface affected).

You may not qualify if:

  • No treatment with topical steroids, calcineurin inhibitors or vitamin D analogs for at least 4 weeks prior to entering the study.
  • No treatment with systemic therapies, including methotrexate, etretinate, PUVA, or cyclosporine 4 weeks prior to entering the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rockefeller University Hospital

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • James Krueger, MD

    Rockefeller University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Co-Investigator

Study Record Dates

First Submitted

November 10, 2006

First Posted

November 14, 2006

Study Start

November 1, 2006

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

October 13, 2011

Record last verified: 2011-10

Locations

US(1)