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

NCT ID: NCT01699412

Last Updated: 2012-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2012-08-31

Brief Summary

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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

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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%.

Conditions

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Graft vs Host Disease Oral Manifestations

Keywords

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Bone Marrow Transplantation Graft vs Host Disease Oral Manifestations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dexamethasone

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

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

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

Clobetasol

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

Group Type EXPERIMENTAL

Clobetasol

Intervention Type DRUG

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

Interventions

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Clobetasol

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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Grupo de Estudos Multicentricos em Onco-Hematologia

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cesar W. Noce, DDS, MSD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal do Rio de Janeiro

Sandra R. Torres, DDS,MSD,PhD

Role: STUDY_CHAIR

Universidade Federal do Rio de Janeiro

Ângelo Maiolino, MD,MSD,PhD

Role: STUDY_CHAIR

Universidade Federal do Rio de Janeiro

Locations

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Clementino Fraga Filho University Hospital

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Hematology and Hemotherapy Center

Campinas, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 22313917 (View on PubMed)

Other Identifiers

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0712.1.146.000-08

Identifier Type: -

Identifier Source: org_study_id