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Narrowband UVB Treatment in Patients With Vitiligo

NCT ID: NCT00398723

Last Updated: 2011-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-11-30

Brief Summary

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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

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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.

Conditions

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Vitiligo

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vitiligo

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

Group Type EXPERIMENTAL

Narrowband UVB

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mary Sullivan-Whalen

OTHER

Sponsor Role lead

Responsible Party

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Mary Sullivan-Whalen

Co-Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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James Krueger, MD

Role: PRINCIPAL_INVESTIGATOR

Rockefeller University

Locations

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Rockefeller University Hospital

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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RUH IRB # JCO 0590

Identifier Type: -

Identifier Source: org_study_id