Oral Chronic Graft-Versus-Host Disease Clinical Trial
Official title:
Narrow-Band UVB Phototherapy for Treatment of Oral Chronic Graft-versus-Host Disease
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.
- At the first visit the following information will be collected about the participant:
original diagnosis, the date and type of transplant, transplant conditioning regimen,
cGVHD prophylaxis regimen, the time when oral cGVHD was first noticed, specific
treatments for oral cGVHD, and any current medications.
- At each visit, and before the participant begins phototherapy treatment, they will
answer a series of questions asking about how their mouth feels and what they are able
to eat. A clinical examination of the mouth will be performed and recorded and
photographs will be taken of the inside of the mouth.
- Participants will then receive phototherapy treatment. This will take approximately
three minutes and will involve opening the mouth and closing the eyes. Following
phototherapy, the participant will be asked several questions on how they tolerated the
treatment. Phototherapy treatments will be done two or three times per week for a total
of 24 treatments. After each treatment, if the participant has not experienced any
discomfort, the phototherapy dose will be increased following a specific protocol.
- After 24 treatments the participant will have the option to continue phototherapy
treatments.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00686855 -
Topical Dexamethasone and Tacrolimus for the Treatment of Oral Chronic Graft-Versus-Host Disease
|
Phase 2 |