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

Phase 3

Completed

• Conditions: Graft vs Host Disease; Oral Manifestations
• Interventions: Drug: Dexamethasone; Drug: Clobetasol

• Registration Number: NCT01699412
• Lead Sponsor: Grupo de Estudos Multicentricos em Onco-Hematologia

Brief Summary

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.

Detailed 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%.

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2012-07
• Study Completion: 2012-08
• Status Verified: 2012-09
• Study First Submitted: 2012-09-27
• Study First Submitted QC: 2012-09-30
• Last Update Submitted: 2012-09-30
• Study First Posted: 2012-10-03
• Last Update Posted: 2012-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone	Dexamethasone	Patients under topical treatment with solution of dexamethasone 0.1 mg/mL associated to nystatin 100,000 UI/mL
Clobetasol	Clobetasol	Patients under topical treatment with solution of clobetasol 0.05% associated with nystatin 100,000 UI/mL

Primary Outcome Measures

Name	Time	Method
Change from baseline in symptoms related to oral cGVHD at 4 weeks	Baseline and 4 weeks	Comparison of symptoms of oral lesions of chronic GVHD, analyzed through visual analogue scale, at baseline and after 4 weeks of topical treatment

Secondary Outcome Measures

Name	Time	Method
Change from baseline in clinical aspects of oral cGVHD at 4 weeks	Baseline and 4 weeks	Comparison of the morphologic response of the oral lesions of chronic GVHD, measured through modified Oral Mucositis Rating Scale

Trial Locations

Locations (2)

Hematology and Hemotherapy Center; 🇧🇷 Campinas, São Paulo, Brazil

Clementino Fraga Filho University Hospital; 🇧🇷 Rio de Janeiro, Brazil