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Clinical Trials/NCT00398723
NCT00398723CompletedNot Applicable

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

Mary Sullivan-Whalen1 site in 1 country20 target enrollmentStarted: November 1, 2006Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
20
Locations
1
Primary Endpoint
Number of melanocytes per unit length of skin surface
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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.

Arms & Interventions

Vitiligo

Experimental

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

Intervention: Narrowband UVB (Device)

Outcomes

Primary Outcomes

Number of melanocytes per unit length of skin surface

Time Frame: pre-treatment, early repigmentation, 75% repigmentation of total body

Secondary Outcomes

  • Clinical improvement(first visit and last visit)

Investigators

Sponsor
Mary Sullivan-Whalen
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Mary Sullivan-Whalen

Co-Investigator

Rockefeller University

Study Sites (1)

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