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.

National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: V. The 2014 Ancillary Therapy and Supportive Care Working Group Report

“…The mainstay of ancillary therapy for symptomatic oral mucosal or erythematous or ulcerative disease is the application of high-potency corticosteroid preparations, although evidence to guide the choice of specific agents is limited (Table 4) [15–17]. Solutions are used mainly when manifestations are generalized, whereas gels, creams, and ointments are used for localized lesions, with gels generally preferable due to their hydrophilic properties.…”

Efficacy and Safety of Topical Corticosteroids for Management of Oral Chronic Graft versus Host Disease

“…From the 6 included studies in (Table 1), budesonide, dexamethasone, and clobetasol were the topical steroid agents evaluated in included studies. Of the reviewed studies, there were 2 RCTs [7, 10], 3 cohort studies [8, 9, 11], and 1 pre-post clinical trial [12]. …”

Tratamento das manifestações orais da doença enxerto contra o hospedeiro crônica: revisão sistêmica da literatura

“…É considerada o padrão ouro para tratamento de doenças autoimunes, sendo usada para avaliar parâmetro de eficácia em ensaios clínicos. 19,24,26 Foi encontrado um relato de caso de tratamento tópico da DECHc oral. 27 Dentre os efeitos adversos observados encontramos o desenvolvimento de infecções oportunistas, principalmente as fúngicas, sendo necessário uso profilático de Nistatina (100.000 UI por ml 4 vezes ao dia).…”

“…26 Possui recomendação A e evidência Ia. 8 Foi encontrado um estudo randomizado duplo cego comparando os efeitos do Clobetasol e a Dexametasona, com excelentes resultados na amostra.…”

“…8 Foi encontrado um estudo randomizado duplo cego comparando os efeitos do Clobetasol e a Dexametasona, com excelentes resultados na amostra. 26 Houve pelo menos remissão parcial em 85% (N=14) dos pacientes com uso de Clobetasol, comparados com o grupo Dexametasona em 33% (N=11). Os efeitos colaterais foram os mesmos qualitativamente nos dois grupos.…”