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Narrowband UVB Treatment in Patients With Vitiligo

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mary Sullivan-Whalen, Rockefeller University
ClinicalTrials.gov Identifier:
NCT00398723
First received: November 10, 2006
Last updated: October 11, 2011
Last verified: October 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Narrowband UVB Phototherapy on Melanocyte Proliferation in Patients With Vitiligo

Resource links provided by NLM:

MedlinePlus related topics: Vitiligo
U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical improvement [ Time Frame: first visit and last visit ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Mary Sullivan-Whalen, Co-Investigator, Rockefeller University
ClinicalTrials.gov Identifier: NCT00398723     History of Changes
Other Study ID Numbers: RUH IRB # JCO 0590
Study First Received: November 10, 2006
Last Updated: October 11, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Rockefeller University:
Narrowband UBV Phototherapy
Skin biopsies

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013