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

Graft vs Host Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01699412
• Other study ID #: 0712.1.146.000-08
• Status: Completed
• Phase: Phase 3
• First received: September 27, 2012
• Last updated: September 30, 2012
• Start date: August 2008
• Est. completion date: August 2012

Study information

• Verified date: September 2012
• Source: Grupo de Estudos Multicentricos em Onco-Hematologia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Clementino Fraga Filho University Hospital of the Federal University of Rio de Janeiro
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Graft vs Host Disease
• Oral Manifestations

Intervention

Drug:
• Clobetasol
Rinse with a solution of clobetasol 0.05% associated to nystatin 100,000 UI/mL, for 1 minute, during 28 days
• Dexamethasone
Rinse with a solution of dexamethasone 0.1 mg/mL associated to nystatin 100,000 UI/mL, for 1 minute, during 28 days

Locations

Country	Name	City	State
Brazil	Hematology and Hemotherapy Center	Campinas	São Paulo
Brazil	Clementino Fraga Filho University Hospital	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Grupo de Estudos Multicentricos em Onco-Hematologia

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in symptoms related to oral cGVHD at 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	Baseline and 4 weeks	No
Secondary	Change from baseline in clinical aspects of oral cGVHD at 4 weeks	Comparison of the morphologic response of the oral lesions of chronic GVHD, measured through modified Oral Mucositis Rating Scale	Baseline and 4 weeks	No