Clinical trial NCT01699412: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Graft vs Host Disease
Oral Manifestations
Keywords: Bone Marrow Transplantation
Graft vs Host Disease
Oral Manifestations
Lead sponsor: Grupo de Estudos Multicentricos em Onco-Hematologia
Sponsor class: NETWORK
First posted: 2012-10-03
Enrollment: 28
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%.

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

Primary outcomes:
measure: Change from baseline in symptoms related to oral cGVHD at 4 weeks
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Change from baseline in clinical aspects of oral cGVHD at 4 weeks
timeFrame: Baseline and 4 weeks
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Hematology and Hemotherapy Center
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Clementino Fraga Filho University Hospital
Study officials:
affiliation: Universidade Federal do Rio de Janeiro
name: Cesar W. Noce, DDS, MSD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal do Rio de Janeiro
name: Sandra R. Torres, DDS,MSD,PhD
role: STUDY_CHAIR
affiliation: Universidade Federal do Rio de Janeiro
name: Ângelo Maiolino, MD,MSD,PhD
role: STUDY_CHAIR
References:
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.