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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

September 27, 2012
September 30, 2012
August 2008
July 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01699412 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Clinical Trial With Clobetasol and Dexamethasone for Topical Treatment of Oral Lesions of Chronic Graft-versus-host Disease
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

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.

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%.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Graft vs Host Disease
  • Oral Manifestations
  • Drug: Clobetasol
    Rinse with a solution of clobetasol 0.05% associated to nystatin 100,000 UI/mL, for 1 minute, during 28 days
  • 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: Dexamethasone
    Patients under topical treatment with solution of dexamethasone 0.1 mg/mL associated to nystatin 100,000 UI/mL
    Intervention: Drug: Dexamethasone
  • Experimental: Clobetasol
    Patients under topical treatment with solution of clobetasol 0.05% associated with nystatin 100,000 UI/mL
    Intervention: Drug: Clobetasol
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
August 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01699412
0712.1.146.000-08
No
Grupo de Estudos Multicentricos em Onco-Hematologia
Grupo de Estudos Multicentricos em Onco-Hematologia
Not Provided
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
Grupo de Estudos Multicentricos em Onco-Hematologia
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP