Narrowband UVB Treatment in Patients With Vitiligo

October 11, 2011 updated by: Mary Sullivan-Whalen

Effects of Narrowband UVB Phototherapy on Melanocyte Proliferation in Patients With Vitiligo

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All patients will receive phototherapy, with narrowband UVB, three times a week for six months, or a total of 78 treatments. 6mm punch skin biopsies (2) will be done prior to starting therapy, once during treatment (2) and at the completion of the study (2). Clinical assessments and photography will be done parallel to the skin biopsies. Results (clinically and histologically) will be analyzed.

Study Type

Interventional

Enrollment (Actual)

20

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

  • United States
    • New York
      • New York, New York, United States, 10021
        • Rockefeller University Hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitiligo
adult patients (age 18 or greater) with extensive vitiligo warranting treatment with whole body NB-UVB
Device: Narrowband UVB
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of melanocytes per unit length of skin surface
Time Frame: pre-treatment, early repigmentation, 75% repigmentation of total body
pre-treatment, early repigmentation, 75% repigmentation of total body

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical improvement
Time Frame: first visit and last visit
first visit and last visit

Collaborators and Investigators

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

Sponsor

Mary Sullivan-Whalen

Investigators

  • Principal Investigator: James Krueger, MD, Rockefeller University

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

November 1, 2006

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

November 10, 2006

First Submitted That Met QC Criteria

November 13, 2006

First Posted (Estimate)

November 14, 2006

Study Record Updates

Last Update Posted (Estimate)

October 13, 2011

Last Update Submitted That Met QC Criteria

October 11, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RUH IRB # JCO 0590

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.

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