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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Grupo de Estudos Multicentricos em Onco-Hematologia
ClinicalTrials.gov Identifier:
NCT01699412
First received: September 27, 2012
Last updated: September 30, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Graft vs Host Disease
Oral Manifestations
Drug: Clobetasol
Drug: Dexamethasone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Grupo de Estudos Multicentricos em Onco-Hematologia:

Primary Outcome Measures:
  • Change from baseline in symptoms related to oral cGVHD at 4 weeks [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    Comparison of the morphologic response of the oral lesions of chronic GVHD, measured through modified Oral Mucositis Rating Scale


Enrollment: 28
Study Start Date: August 2008
Study Completion Date: August 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01699412

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

Publications:
Responsible Party: Grupo de Estudos Multicentricos em Onco-Hematologia
ClinicalTrials.gov Identifier: NCT01699412     History of Changes
Other Study ID Numbers: 0712.1.146.000-08
Study First Received: September 27, 2012
Last Updated: September 30, 2012
Health Authority: Brazil: Clementino Fraga Filho University Hospital of the Federal University of Rio de Janeiro

Keywords provided by Grupo de Estudos Multicentricos em Onco-Hematologia:
Bone Marrow Transplantation
Graft vs Host Disease
Oral Manifestations

Additional relevant MeSH terms:
Graft vs Host Disease
Oral Manifestations
Immune System Diseases
Mouth Diseases
Stomatognathic Diseases
Signs and Symptoms
Dexamethasone acetate
Clobetasol
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014