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

• ClinicalTrials.gov Identifier: NCT01699412
• Recruitment Status: Completed
• First Posted: October 3, 2012
• Last Update Posted: October 3, 2012
• Sponsor: Grupo de Estudos Multicentricos em Onco-Hematologia
• Information provided by (Responsible Party): Grupo de Estudos Multicentricos em Onco-Hematologia

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Graft vs Host Disease; Oral Manifestations	Drug: Clobetasol; Drug: Dexamethasone	Phase 3

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%.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, 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
• Study Start Date: August 2008
• Actual Primary Completion Date: July 2012
• Actual Study Completion Date: August 2012

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Change from baseline in symptoms related to oral cGVHD at 4 weeks [ Time Frame: Baseline and 4 weeks ]
   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 :

1. Change from baseline in clinical aspects of oral cGVHD at 4 weeks [ Time Frame: Baseline and 4 weeks ]
   Comparison of the morphologic response of the oral lesions of chronic GVHD, measured through modified Oral Mucositis Rating Scale

Eligibility Criteria

• Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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:

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.

• Responsible Party: Grupo de Estudos Multicentricos em Onco-Hematologia
• ClinicalTrials.gov Identifier: NCT01699412
• Other Study ID Numbers: 0712.1.146.000-08
• First Posted: October 3, 2012
• Last Update Posted: October 3, 2012
• Last Verified: September 2012

Keywords provided by Grupo de Estudos Multicentricos em Onco-Hematologia:

Bone Marrow Transplantation; Graft vs Host Disease; Oral Manifestations

Additional relevant MeSH terms:

Oral Manifestations; Mouth Diseases; Dexamethasone; Clobetasol; Graft vs Host Disease; Immune System Diseases; Stomatognathic Diseases; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents