Randomized double-blind clinical trial comparing clobetasol and dexamethasone for the topical treatment of symptomatic oral chronic graft-versus-host disease.

Abstract

Patients who undergo allogeneic stem cell transplantation frequently develop an immunologic disease caused by the reactivation of the graft to the host tissues. This disease is called graft-versus-host disease (GVHD) and it is usually a systemic disorder. In a large proportion of cases, oral disorders that are related to a chronic phase of GVHD (cGVHD) occur, and their treatment involves the use of topical immunosuppressive drugs. Several medications have been studied for this purpose, but only a small number of clinical trials have been published. The present study is a randomized, double-blind clinical trial that compares topical clobetasol and dexamethasone for the treatment of symptomatic oral cGVHD. Patients were randomly assigned to treatment with clobetasol propionate .05% or dexamethasone .1 mg/mL for 28 days. In both arms, nystatin 100,000 IU/mL was administered with the corticosteroid. Oral lesions were evaluated by the modified oral mucositis rating scale (mOMRS) and symptoms were registered using a visual analogue scale. Thirty-five patients were recruited, and 32 patients were randomized into the study groups: 18 patients (56.3%) to the dexamethasone group and 14 patients (43.8%) to the clobetasol group. The use of clobetasol resulted in a significant reduction in mOMRS total score (P = .04) and in the score for ulcers (P = .03). In both groups, there was significant symptomatic improvement but the response was significantly greater in the clobetasol group (P = .02). In conclusion, clobetasol was significantly more effective than dexamethasone for the amelioration of symptoms and clinical aspects of oral lesions in cGVHD.

• Authors: Cesar W Noce, Alessandra Gomes, Vanessa Shcaira, Maria Elvira P Corrêa, Maria Cláudia R Moreira, Arley Silva Júnior, Lúcio Souza Gonçalves, Marcia Garnica, Angelo Maiolino, Sandra R Torres
• Journal: Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation (Biol Blood Marrow Transplant) Vol. 20 Issue 8 Pg. 1163-8 (Aug 2014) ISSN: 1523-6536 [Electronic] United States
• PMID: 24727333 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2014 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

Chemical References

• Anti-Inflammatory Agents
• Dexamethasone
• Clobetasol

Topics

• Administration, Topical
• Adult
• Aged
• Anti-Inflammatory Agents (therapeutic use)
• Clobetasol (therapeutic use)
• Dexamethasone (therapeutic use)
• Double-Blind Method
• Female
• Graft vs Host Disease (drug therapy)
• Hematopoietic Stem Cell Transplantation (methods)
• Humans
• Male
• Middle Aged
• Mouth Diseases (drug therapy)
• Transplantation Conditioning (methods)
• Transplantation, Homologous (methods)