<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01699412</url>
  </required_header>
  <id_info>
    <org_study_id>0712.1.146.000-08</org_study_id>
    <nct_id>NCT01699412</nct_id>
  </id_info>
  <brief_title>Clinical Trial With Clobetasol and Dexamethasone for Topical Treatment of Oral Lesions of Chronic Graft-versus-host Disease</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Grupo de Estudos Multicentricos em Onco-Hematologia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Grupo de Estudos Multicentricos em Onco-Hematologia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to perform a randomized, double-blind, clinical trial comparing&#xD;
      the topical treatment with clobetasol or dexamethasone for symptomatic oral lesions of&#xD;
      chronic graft-versus-host disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients with symptomatic oral lesions of cGVHD were included in the study. Exclusion&#xD;
      criteria were patients with 12 years or less of age, history of allergy to any of the studied&#xD;
      medications and patients already under other topical treatment for oral lesions of cGVHD.&#xD;
      Patients were randomly assigned between two study groups: one group rinsed with a solution of&#xD;
      clobetasol propionate 0.05% associated to nystatin 100,000 UI/mL; and another group rinsed&#xD;
      with a solution of dexamethasone 0.1 mg/ml associated to nystatin 100,000 UI/mL. Patients&#xD;
      were instructed to use the solution 3 times a day, during 1 minute, for 28 days. Clinical&#xD;
      exams were performed at baseline and after 28 days. Patients were evaluated by an oral&#xD;
      medicine expert, previously calibrated for evaluation of oral cGVHD lesions. Oral lesions of&#xD;
      cGVHD were diagnosed according to NIH 2005 criteria, and graded according to the modified&#xD;
      oral mucositis rating scale. Evaluation of the symptoms of the oral mucosa and of xerostomia&#xD;
      were performed through visual analogue scale. Samples for fungal culture were obtained before&#xD;
      and after the topical treatment. Results were submitted to a descriptive analysis. Chi-square&#xD;
      was used for the comparison of categorical variables. Mann-Whitney and Wilcoxon tests were&#xD;
      used for the comparison of measurable data inter and intra-groups, respectively. Significance&#xD;
      level was set at 5%.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2008</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">July 2012</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in symptoms related to oral cGVHD at 4 weeks</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>Comparison of symptoms of oral lesions of chronic GVHD, analyzed through visual analogue scale, at baseline and after 4 weeks of topical treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in clinical aspects of oral cGVHD at 4 weeks</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>Comparison of the morphologic response of the oral lesions of chronic GVHD, measured through modified Oral Mucositis Rating Scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Graft vs Host Disease</condition>
  <condition>Oral Manifestations</condition>
  <arm_group>
    <arm_group_label>Dexamethasone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients under topical treatment with solution of dexamethasone 0.1 mg/mL associated to nystatin 100,000 UI/mL</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clobetasol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients under topical treatment with solution of clobetasol 0.05% associated with nystatin 100,000 UI/mL</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clobetasol</intervention_name>
    <description>Rinse with a solution of clobetasol 0.05% associated to nystatin 100,000 UI/mL, for 1 minute, during 28 days</description>
    <arm_group_label>Clobetasol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Rinse with a solution of dexamethasone 0.1 mg/mL associated to nystatin 100,000 UI/mL, for 1 minute, during 28 days</description>
    <arm_group_label>Dexamethasone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with symptomatic oral lesions of chronic graft-versus-host disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with less than 12 years of age&#xD;
&#xD;
          -  Patients physically of mentally disabled&#xD;
&#xD;
          -  History of allergy to any of the medications under study&#xD;
&#xD;
          -  Patients already under topical treatment for oral lesions of chronic GVHD&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cesar W. Noce, DDS, MSD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade Federal do Rio de Janeiro</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sandra R. Torres, DDS,MSD,PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Universidade Federal do Rio de Janeiro</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ângelo Maiolino, MD,MSD,PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Universidade Federal do Rio de Janeiro</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hematology and Hemotherapy Center</name>
      <address>
        <city>Campinas</city>
        <state>São Paulo</state>
        <zip>13083-878</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clementino Fraga Filho University Hospital</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>21941-913</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>22313917</PMID>
  </reference>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>September 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>September 30, 2012</last_update_submitted>
  <last_update_submitted_qc>September 30, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 3, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bone Marrow Transplantation</keyword>
  <keyword>Graft vs Host Disease</keyword>
  <keyword>Oral Manifestations</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oral Manifestations</mesh_term>
    <mesh_term>Bronchiolitis Obliterans Syndrome</mesh_term>
    <mesh_term>Graft vs Host Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Clobetasol</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01699412
org study id: 0712.1.146.000-08
nct id: NCT01699412
lead sponsor: 
has dmc: No
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%.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change from baseline in symptoms related to oral cGVHD at 4 weeks
time frame: Baseline and 4 weeks
description: Comparison of symptoms of oral lesions of chronic GVHD, analyzed through visual analogue scale, at baseline and after 4 weeks of topical treatment
measure: Change from baseline in clinical aspects of oral cGVHD at 4 weeks
time frame: Baseline and 4 weeks
description: Comparison of the morphologic response of the oral lesions of chronic GVHD, measured through modified Oral Mucositis Rating Scale
arm group label: Dexamethasone
arm group type: Experimental
description: Patients under topical treatment with solution of dexamethasone 0.1 mg/mL associated to nystatin 100,000 UI/mL
arm group label: Clobetasol
arm group type: Experimental
description: Patients under topical treatment with solution of clobetasol 0.05% associated with nystatin 100,000 UI/mL
intervention type: Drug
intervention name: Clobetasol
description: Rinse with a solution of clobetasol 0.05% associated to nystatin 100,000 UI/mL, for 1 minute, during 28 days
arm group label: Clobetasol
intervention type: Drug
intervention name: Dexamethasone
description: Rinse with a solution of dexamethasone 0.1 mg/mL associated to nystatin 100,000 UI/mL, for 1 minute, during 28 days
arm group label: Dexamethasone
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
last name: Cesar W. Noce, DDS, MSD
role: Principal Investigator
affiliation: Universidade Federal do Rio de Janeiro
last name: Sandra R. Torres, DDS,MSD,PhD
role: Study Chair
affiliation: Universidade Federal do Rio de Janeiro
last name: Ângelo Maiolino, MD,MSD,PhD
role: Study Chair
affiliation: Universidade Federal do Rio de Janeiro
facility: 
facility: 
country: Brazil
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.
PMID: 22313917
responsible party type: Sponsor
mesh term: Oral Manifestations
mesh term: Bronchiolitis Obliterans Syndrome
mesh term: Graft vs Host Disease
mesh term: Dexamethasone
mesh term: Clobetasol