Phase II Study of Photobiomodulation Therapy Using Thor LX2.3 to Treat Oral Chronic Graft-Versus-Host Disease After Allogeneic Stem Cell Transplant

What this Trial Is About

Researchers are evaluating photobiomodulation PBM therapy using the Thor LX2.3 device to determine its safety and effectiveness for treating oral chronic Graft-Versus-Host Disease GVHD in patients who have received allogeneic stem cell transplants allo-HCT. This Phase II trial is randomized and double-blind, aiming to compare PBM therapy against a placebo sham device in both adult and pediatric participants with oral GVHD. Participants diagnosed with oral chronic GVHD who have previously undergone allo-HCT are randomly assigned to receive either the active PBM treatment or a placebo sham device. The treatment is administered daily for 28 days using the Thor LX2.3 therapy system or the sham device, respectively. The study monitors response rates 28 days after treatment to assess efficacy and safety. During the trial, participants will be monitored for their response to the therapy, including assessments of oral symptoms using standardized scoring. Stable use of other oral topical treatments is allowed if maintained for at least two weeks prior to enrollment. Researchers will collect data on the response rate at 28 days post-treatment. Safety is closely observed, and participants must comply with follow-up visits, supportive care, and research tests throughout the study period.

A Study of Photobiomodulation (PBM) Therapy in People With Oral Graft-Versus-Host Disease (GVHD) After Stem Cell Transplant