title: 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.affiliation: Department of Oral Pathology and Diagnosis, School of Dentistry, and Oral Health Program, Hospital Clementino Fraga Filho, Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, Brazil.
authors.forename: Cesar W
authors.initials: CW
authors.lastname: Noce
authors.affiliation: Department of Oral Pathology and Diagnosis, School of Dentistry, and Oral Health Program, Hospital Clementino Fraga Filho, Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, Brazil.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Gomes
authors.affiliation: Universidade Estadual de Campinas (UNICAMP), Campinas, Brazil.
authors.forename: Vanessa
authors.initials: V
authors.lastname: Shcaira
authors.affiliation: Universidade Estadual de Campinas (UNICAMP), Campinas, Brazil.
authors.forename: Maria Elvira P
authors.initials: ME
authors.lastname: Corrêa
authors.affiliation: Hematology Service, Hospital Clementino Fraga Filho, Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, Brazil.
authors.forename: Maria Cláudia R
authors.initials: MC
authors.lastname: Moreira
authors.affiliation: Department of Oral Pathology and Diagnosis, School of Dentistry, and Oral Health Program, Hospital Clementino Fraga Filho, Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, Brazil.
authors.forename: Arley
authors.initials: A
authors.lastname: Silva Júnior
authors.affiliation: Department of Oral Pathology and Diagnosis, School of Dentistry, and Oral Health Program, Hospital Clementino Fraga Filho, Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, Brazil.
authors.forename: Lúcio Souza
authors.initials: LS
authors.lastname: Gonçalves
authors.affiliation: Hematology Service, Hospital Clementino Fraga Filho, Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, Brazil.
authors.forename: Marcia
authors.initials: M
authors.lastname: Garnica
authors.affiliation: Hematology Service, Hospital Clementino Fraga Filho, Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, Brazil. Electronic address: maiolino@hucff.ufrj.br.
authors.forename: Angelo
authors.initials: A
authors.lastname: Maiolino
authors.affiliation: Department of Oral Pathology and Diagnosis, School of Dentistry, and Oral Health Program, Hospital Clementino Fraga Filho, Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, Brazil.
authors.forename: Sandra R
authors.initials: SR
authors.lastname: Torres
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D002990:Clobetasol / Q000627:therapeutic use*; D003907:Dexamethasone / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006086:Graft vs Host Disease / Q000188:drug therapy*; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009059:Mouth Diseases / Q000188:drug therapy*; D019172:Transplantation Conditioning / Q000379:methods*; D014184:Transplantation, Homologous / Q000379:methods*
chemical_list: D000893:Anti-Inflammatory Agents; D003907:Dexamethasone; D002990:Clobetasol
keywords: Allogeneic stem cell transplantation; Clinical trial; Clobetasol; Graft-versus-host disease; Oral disease; Topical treatment