NCT00374257

Brief Summary

The purpose of this trial is to find out how effective Narrow Band-Ultraviolet Light B (NB-UVB) phototherapy is in treating oral cGVHD. NB-UVB Phototherapy involves exposing the inside of the mouth to light of a particular spectrum (a specific wavelength of light, 311nm) of the ultraviolet band, called NB-UVB. It is known that narrow band ultraviolet light therapy can improve symptoms in patients with skin chronic GVHD.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2006

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 8, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 11, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

December 19, 2025

Status Verified

March 1, 2010

Enrollment Period

2.1 years

First QC Date

September 8, 2006

Last Update Submit

December 12, 2025

Conditions

Oral Chronic Graft-versus-host Disease

Keywords

NB-UVBcGVHD

Outcome Measures

Primary Outcomes (1)

  • To clinically evaluate the treatment efficacy of NB-UVB phototherapy in the management of oral cGVHD.

    4 years

Secondary Outcomes (2)

  • To evaluate the convenience, ease of use, tolerability and practicality of NB-UVB phototherapy in this patient population

    4 years

  • to determine the effective maintenance doses/regimens in participants with good response for long-term management.

    4 years

Study Arms (1)

Active intraoral NBUVB therapy

EXPERIMENTAL
Procedure: Narrow-Band UVB Phototherapy

Interventions

Narrow-Band UVB PhototherapyPROCEDURE

Performed either two or three times per week for a total of 24 treatments

Active intraoral NBUVB therapy

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with oral chronic graft-versus-host disease
  • years of age or older
  • Stable cGVHD medication regimen for the four weeks prior to study enrollment

You may not qualify if:

  • New immunomodulatory medications or increasing dosage of current immunomodulatory medications during the four weeks prior to study enrollment
  • Concurrent extracorporeal photopheresis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Study Officials

  • Nathaniel S. Treister, DMD, DMSc

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 8, 2006

First Posted

September 11, 2006

Study Start

August 1, 2006

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

December 19, 2025

Record last verified: 2010-03

Locations

US(2)