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

Information source: Grupo de Estudos Multicentricos em Onco-Hematologia
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Graft vs Host Disease; Oral Manifestations

Intervention: Clobetasol (Drug); Dexamethasone (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Grupo de Estudos Multicentricos em Onco-Hematologia

Official(s) and/or principal investigator(s):
Cesar W. Noce, DDS, MSD, Principal Investigator, Affiliation: Universidade Federal do Rio de Janeiro
Sandra R. Torres, DDS,MSD,PhD, Study Chair, Affiliation: Universidade Federal do Rio de Janeiro
Ângelo Maiolino, MD,MSD,PhD, Study Chair, Affiliation: Universidade Federal do Rio de Janeiro

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.

Clinical Details

Official title: Randomized Double-blid Clinical Trial Comparing the Topical Treatment With Clobetasol and Dexamethasone for Oral Lesions of Chronic Graft-versus-host Disease in Allogeneic Hematopoietic Stem Cell Transplant Recipients

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change from baseline in symptoms related to oral cGVHD at 4 weeks

Secondary outcome: Change from baseline in clinical aspects of oral cGVHD at 4 weeks

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%.

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Clementino Fraga Filho University Hospital, Rio de Janeiro 21941-913, Brazil

Hematology and Hemotherapy Center, Campinas, São Paulo 13083-878, Brazil

Additional Information

Related publications:

Noce CW, Gomes A, Copello A, Barbosa RD, Sant'anna S, Moreira MC, Correa ME, Maiolino A, Torres SR. Oral involvement of chronic graft-versus-host disease in hematopoietic stem cell transplant recipients. Gen Dent. 2011 Nov-Dec;59(6):458-62; quiz 463-4.

Starting date: August 2008
Last updated: September 30, 2012

Page last updated: August 23, 2015

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