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Narrowband UVB Treatment in Patients With Vitiligo

Primary Purpose

Vitiligo

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Narrowband UVB

About this trial

This is an interventional treatment trial for Vitiligo focused on measuring Narrowband UBV Phototherapy, Skin biopsies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Rockefeller University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vitiligo

Arm Description

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

Outcomes

Primary Outcome Measures

Number of melanocytes per unit length of skin surface

Secondary Outcome Measures

Clinical improvement

Full Information

NCT ID

NCT00398723

First Posted

November 10, 2006

Last Updated

October 11, 2011

Sponsor

Mary Sullivan-Whalen

1. Study Identification

Unique Protocol Identification Number

NCT00398723

Brief Title

Narrowband UVB Treatment in Patients With Vitiligo

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Completed

Study Start Date

November 2006 (undefined)

Primary Completion Date

November 2007 (Actual)

Study Completion Date

November 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Mary Sullivan-Whalen

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitiligo

Keywords

Narrowband UBV Phototherapy, Skin biopsies

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vitiligo

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Narrowband UVB

Intervention Description

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 Measure Information:

Title

Number of melanocytes per unit length of skin surface

Time Frame

pre-treatment, early repigmentation, 75% repigmentation of total body

Secondary Outcome Measure Information:

Title

Clinical improvement

Time Frame

first visit and last visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James Krueger, MD

Organizational Affiliation

Rockefeller University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rockefeller University Hospital

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

12. IPD Sharing Statement

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Narrowband UVB Treatment in Patients With Vitiligo

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