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An Open-Label Phase II Randomized Trial of Topical Dexamethasone and Tacrolimus Solutions for the Treatment of Oral Chronic Graft-versus-Host Disease Nathaniel Treister, Shuli Li, Haesook Kim, Mark Lerman, Ahmed Sultan, Edwin P. Alyea, Philippe Armand, Corey Cutler, Vincent Ho, John Koreth, Joseph H. Antin, Robert Soiffer Biology of Blood and Marrow Transplantation Volume 22, Issue 11, Pages (November 2016) DOI: /j.bbmt Copyright © 2016 The American Society for Blood and Marrow Transplantation Terms and Conditions
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Figure 1 Study flow chart. Note that the tacrolimus arm was closed early based on interim analysis. Biology of Blood and Marrow Transplantation , DOI: ( /j.bbmt ) Copyright © 2016 The American Society for Blood and Marrow Transplantation Terms and Conditions
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Figure 2 Frequency and magnitude of clinical responses to topical dexamethasone and topical tacrolimus solutions. Biology of Blood and Marrow Transplantation , DOI: ( /j.bbmt ) Copyright © 2016 The American Society for Blood and Marrow Transplantation Terms and Conditions
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Figure 3 Clinical and histopathological response in a representative subject on the dexamethasone arm. Baseline visit demonstrated (A) diffuse reticulation, erythema, and ulceration of the right buccal mucosa, and (B) a dense band-like infiltrate of chronic inflammatory cells at the basement membrane interface histopathologically. End-of-treatment visit demonstrated (C) significant reduction in all clinical features and (D) significant reduction in the intensity of the band-like infiltrate histopathologically. Biology of Blood and Marrow Transplantation , DOI: ( /j.bbmt ) Copyright © 2016 The American Society for Blood and Marrow Transplantation Terms and Conditions
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Figure 4 Tacrolimus serum levels in subjects in the topical tacrolimus arm. There was no attempt to obtain trough levels before the first daily rinse. Each line represents an individual participant. Biology of Blood and Marrow Transplantation , DOI: ( /j.bbmt ) Copyright © 2016 The American Society for Blood and Marrow Transplantation Terms and Conditions
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