Clinical Trial With Clobetasol and Dexamethasone for Topical Treatment of Oral Lesions of Chronic Graft-versus-host Disease
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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 |
- 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
- 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 |
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| Brazil | |
| Hematology and Hemotherapy Center | |
| Campinas, São Paulo, Brazil, 13083-878 | |
| Clementino Fraga Filho University Hospital | |
| Rio de Janeiro, Brazil, 21941-913 | |
| Principal Investigator: | Cesar W. Noce, DDS, MSD | Federal University of Rio de Janeiro |
| Study Chair: | Sandra R. Torres, DDS,MSD,PhD | Federal University of Rio de Janeiro |
| Study Chair: | Ângelo Maiolino, MD,MSD,PhD | Federal University of 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 May 21, 2013