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Narrowband UVB Treatment in Patients With Vitiligo

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. Identifier: NCT00398723
Recruitment Status : Completed
First Posted : November 14, 2006
Last Update Posted : October 13, 2011
Information provided by (Responsible Party):
Mary Sullivan-Whalen, Rockefeller University

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.

Condition or disease Intervention/treatment
Vitiligo Device: Narrowband UVB

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  (Clinical Trial)
Actual Enrollment : 20 participants
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
Study Start Date : November 2006
Primary Completion Date : November 2007
Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitiligo
U.S. FDA Resources

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

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

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

Information from the National Library of Medicine

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

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.

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 identifier (NCT number): NCT00398723

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

Responsible Party: Mary Sullivan-Whalen, Co-Investigator, Rockefeller University Identifier: NCT00398723     History of Changes
Other Study ID Numbers: RUH IRB # JCO 0590
First Posted: November 14, 2006    Key Record Dates
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:
Pigmentation Disorders
Skin Diseases