Ignite Creation Date:
2024-05-06 @ 12:58 AM
Last Modification Date:
2024-10-26 @ 10:57 AM
Study NCT ID:
NCT01699412
Status:
COMPLETED
Last Update Posted:
2012-10-03
First Post:
2012-09-27
Brief Title:
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
Organization:
Grupo de Estudos Multicentricos em Onco-Hematologia
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 005 associated to nystatin 100000 UImL and another group rinsed with a solution of dexamethasone 01 mgml associated to nystatin 100000 UImL 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None