Clinical Trial With Clobetasol and Dexamethasone for Topical Treatment of Oral Lesions of Chronic Graft-versus-host Disease

Grupo de Estudos Multicentricos em Onco-Hematologia

Status and phase: Completed; Phase 3

Conditions: Oral Manifestations; Graft vs Host Disease

Treatments: Drug: Dexamethasone; Drug: Clobetasol

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01699412

0712.1.146.000-08

Details and patient eligibility

About

The purpose of this study is to perform a randomized, double-blind, clinical trial comparing the topical treatment with clobetasol or dexamethasone for symptomatic oral lesions of chronic graft-versus-host disease.

Full description

All patients with symptomatic oral lesions of cGVHD were included in the study. Exclusion criteria were patients with 12 years or less of age, history of allergy to any of the studied medications and patients already under other topical treatment for oral lesions of cGVHD. Patients were randomly assigned between two study groups: one group rinsed with a solution of clobetasol propionate 0.05% associated to nystatin 100,000 UI/mL; and another group rinsed with a solution of dexamethasone 0.1 mg/ml associated to nystatin 100,000 UI/mL. Patients were instructed to use the solution 3 times a day, during 1 minute, for 28 days. Clinical exams were performed at baseline and after 28 days. Patients were evaluated by an oral medicine expert, previously calibrated for evaluation of oral cGVHD lesions. Oral lesions of cGVHD were diagnosed according to NIH 2005 criteria, and graded according to the modified oral mucositis rating scale. Evaluation of the symptoms of the oral mucosa and of xerostomia were performed through visual analogue scale. Samples for fungal culture were obtained before and after the topical treatment. Results were submitted to a descriptive analysis. Chi-square was used for the comparison of categorical variables. Mann-Whitney and Wilcoxon tests were used for the comparison of measurable data inter and intra-groups, respectively. Significance level was set at 5%.

Enrollment: 28 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with symptomatic oral lesions of chronic graft-versus-host disease

Exclusion criteria

• Patients with less than 12 years of age
• Patients physically of mentally disabled
• History of allergy to any of the medications under study
• Patients already under topical treatment for oral lesions of chronic GVHD

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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28 participants in 2 patient groups

Dexamethasone

Experimental group

Description:

Patients under topical treatment with solution of dexamethasone 0.1 mg/mL associated to nystatin 100,000 UI/mL

Treatment:

Drug: Dexamethasone

Clobetasol

Experimental group

Description:

Patients under topical treatment with solution of clobetasol 0.05% associated with nystatin 100,000 UI/mL

Treatment:

Drug: Clobetasol