Narrowband UVB Treatment in Patients With Vitiligo | NCT00398723

Studies
Narrowband UVB Treatment in Patients With Vitiligo

NCT00398723

Sponsor

Mary Sullivan-Whalen

Status

Completed

Last Update Posted

Oct 13, 2011Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Vitiligo

Interventions

Narrowband UVB

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Nov 2007Actual

Completion Date

Nov 2007Actual

First Submitted Date

Nov 10, 2006

First Submission Date that Met QC Criteria

Nov 13, 2006

First Posted Date

Nov 14, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 11, 2011

Last Update Posted Date

Oct 13, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vitiligo	Experimental	adult patients (age 18 or greater) with extensive vitiligo warranting treatment with whole body NB-UVB	Device: Narrowband UVB

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Narrowband UVB	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of melanocytes per unit length of skin surface		pre-treatment, early repigmentation, 75% repigmentation of total body

Secondary Outcomes

Measure	Description	Time Frame
Clinical improvement		first visit and last visit

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
James Krueger, MD	Rockefeller University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rockefeller University Hospital		New York	New York	10021	United States

Condition Browse Module

MeSH Terms

ID	Term
D014820	Vitiligo

Ancestor Terms

ID	Term
D017496	Hypopigmentation
D010859	Pigmentation Disorders
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided