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

Sponsor

Grupo de Estudos Multicentricos em Onco-Hematologia (Other)

Overall Status

Completed

CT.gov ID

NCT01699412

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Graft vs Host Disease Oral Manifestations	Drug: Clobetasol Drug: Dexamethasone	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Aug 1, 2008

Actual Primary Completion Date :

Jul 1, 2012

Actual Study Completion Date :

Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dexamethasone Patients under topical treatment with solution of dexamethasone 0.1 mg/mL associated to nystatin 100,000 UI/mL	Drug: Dexamethasone Rinse with a solution of dexamethasone 0.1 mg/mL associated to nystatin 100,000 UI/mL, for 1 minute, during 28 days
Experimental: Clobetasol Patients under topical treatment with solution of clobetasol 0.05% associated with nystatin 100,000 UI/mL	Drug: Clobetasol Rinse with a solution of clobetasol 0.05% associated to nystatin 100,000 UI/mL, for 1 minute, during 28 days

Arm

Intervention/Treatment

Experimental: Dexamethasone

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

Drug: Dexamethasone

Rinse with a solution of dexamethasone 0.1 mg/mL associated to nystatin 100,000 UI/mL, for 1 minute, during 28 days

Experimental: Clobetasol

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

Drug: Clobetasol

Rinse with a solution of clobetasol 0.05% associated to nystatin 100,000 UI/mL, for 1 minute, during 28 days

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hematology and Hemotherapy Center	Campinas	São Paulo	Brazil	13083-878
2	Clementino Fraga Filho University Hospital	Rio de Janeiro		Brazil	21941-913

Sponsors and Collaborators

Grupo de Estudos Multicentricos em Onco-Hematologia

Investigators

Principal Investigator: Cesar W. Noce, DDS, MSD, Universidade Federal do Rio de Janeiro
Study Chair: Sandra R. Torres, DDS,MSD,PhD, Universidade Federal do Rio de Janeiro
Study Chair: Ângelo Maiolino, MD,MSD,PhD, Universidade Federal do Rio de Janeiro