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

Primary Purpose

Graft vs Host Disease, Oral Manifestations

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Clobetasol
Dexamethasone
Sponsored by
Grupo de Estudos Multicentricos em Onco-Hematologia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Graft vs Host Disease focused on measuring Bone Marrow Transplantation, Graft vs Host Disease, Oral Manifestations

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hematology and Hemotherapy Center
  • Clementino Fraga Filho University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dexamethasone

Clobetasol

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 27, 2012
Last Updated
September 30, 2012
Sponsor
Grupo de Estudos Multicentricos em Onco-Hematologia
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1. Study Identification

Unique Protocol Identification Number
NCT01699412
Brief Title
Clinical Trial With Clobetasol and Dexamethasone for Topical Treatment of Oral Lesions of Chronic Graft-versus-host Disease
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 Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Grupo de Estudos Multicentricos em Onco-Hematologia

4. Oversight

Data Monitoring Committee
No

5. 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.
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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft vs Host Disease, Oral Manifestations
Keywords
Bone Marrow Transplantation, Graft vs Host Disease, Oral Manifestations

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone
Arm Type
Experimental
Arm Description
Patients under topical treatment with solution of dexamethasone 0.1 mg/mL associated to nystatin 100,000 UI/mL
Arm Title
Clobetasol
Arm Type
Experimental
Arm Description
Patients under topical treatment with solution of clobetasol 0.05% associated with nystatin 100,000 UI/mL
Intervention Type
Drug
Intervention Name(s)
Clobetasol
Intervention Description
Rinse with a solution of clobetasol 0.05% associated to nystatin 100,000 UI/mL, for 1 minute, during 28 days
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Rinse with a solution of dexamethasone 0.1 mg/mL associated to nystatin 100,000 UI/mL, for 1 minute, during 28 days
Primary Outcome Measure Information:
Title
Change from baseline in symptoms related to oral cGVHD at 4 weeks
Description
Comparison of symptoms of oral lesions of chronic GVHD, analyzed through visual analogue scale, at baseline and after 4 weeks of topical treatment
Time Frame
Baseline and 4 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in clinical aspects of oral cGVHD at 4 weeks
Description
Comparison of the morphologic response of the oral lesions of chronic GVHD, measured through modified Oral Mucositis Rating Scale
Time Frame
Baseline and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cesar W. Noce, DDS, MSD
Organizational Affiliation
Universidade Federal do Rio de Janeiro
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sandra R. Torres, DDS,MSD,PhD
Organizational Affiliation
Universidade Federal do Rio de Janeiro
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ângelo Maiolino, MD,MSD,PhD
Organizational Affiliation
Universidade Federal do Rio de Janeiro
Official's Role
Study Chair
Facility Information:
Facility Name
Hematology and Hemotherapy Center
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13083-878
Country
Brazil
Facility Name
Clementino Fraga Filho University Hospital
City
Rio de Janeiro
ZIP/Postal Code
21941-913
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
22313917
Citation
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.
Results Reference
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Clinical Trial With Clobetasol and Dexamethasone for Topical Treatment of Oral Lesions of Chronic Graft-versus-host Disease

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