We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Narrowband UVB Treatment in Patients With Vitiligo

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00398723
First Posted: November 14, 2006
Last Update Posted: October 13, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mary Sullivan-Whalen, Rockefeller University
  Purpose

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.


Condition Intervention
Vitiligo Device: Narrowband UVB

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Narrowband UVB Phototherapy on Melanocyte Proliferation in Patients With Vitiligo

Resource links provided by NLM:


Further study details as provided by Mary Sullivan-Whalen, Rockefeller University:

Primary Outcome Measures:
  • Number of melanocytes per unit length of skin surface [ Time Frame: pre-treatment, early repigmentation, 75% repigmentation of total body ]

Secondary Outcome Measures:
  • Clinical improvement [ Time Frame: first visit and last visit ]

Enrollment: 20
Study Start Date: November 2006
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00398723


Locations
United States, New York
Rockefeller University Hospital
New York, New York, United States, 10021
Sponsors and Collaborators
Mary Sullivan-Whalen
Investigators
Principal Investigator: James Krueger, MD Rockefeller University
  More Information

Responsible Party: Mary Sullivan-Whalen, Co-Investigator, Rockefeller University
ClinicalTrials.gov Identifier: NCT00398723     History of Changes
Other Study ID Numbers: RUH IRB # JCO 0590
First Submitted: November 10, 2006
First Posted: November 14, 2006
Last Update Posted: October 13, 2011
Last Verified: October 2011

Keywords provided by Mary Sullivan-Whalen, Rockefeller University:
Narrowband UBV Phototherapy
Skin biopsies

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases


To Top