NCT01699412

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2008

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 3, 2012

Completed
Last Updated

October 3, 2012

Status Verified

September 1, 2012

Enrollment Period

3.9 years

First QC Date

September 27, 2012

Last Update Submit

September 30, 2012

Conditions

Graft vs Host DiseaseOral Manifestations

Keywords

Bone Marrow TransplantationGraft vs Host DiseaseOral Manifestations

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in symptoms related to oral cGVHD at 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

    Baseline and 4 weeks

Secondary Outcomes (1)

  • Change from baseline in clinical aspects of oral cGVHD at 4 weeks

    Baseline and 4 weeks

Study Arms (2)

Dexamethasone

EXPERIMENTAL

Patients under topical treatment with solution of dexamethasone 0.1 mg/mL associated to nystatin 100,000 UI/mL

Drug: Dexamethasone

Clobetasol

EXPERIMENTAL

Patients under topical treatment with solution of clobetasol 0.05% associated with nystatin 100,000 UI/mL

Drug: Clobetasol

Interventions

ClobetasolDRUG

Rinse with a solution of clobetasol 0.05% associated to nystatin 100,000 UI/mL, for 1 minute, during 28 days

Clobetasol
DexamethasoneDRUG

Rinse with a solution of dexamethasone 0.1 mg/mL associated to nystatin 100,000 UI/mL, for 1 minute, during 28 days

Dexamethasone

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with symptomatic oral lesions of chronic graft-versus-host disease

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clementino Fraga Filho University Hospital

Rio de Janeiro, Rio de Janeiro, 21941-913, Brazil

Location

Hematology and Hemotherapy Center

Campinas, São Paulo, 13083-878, Brazil

Location

Related Publications (1)

  • 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: 22313917BACKGROUND

MeSH Terms

Conditions

Graft vs Host DiseaseOral Manifestations

Interventions

ClobetasolDexamethasone

Condition Hierarchy (Ancestors)

Immune System DiseasesMouth DiseasesStomatognathic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BetamethasoneSteroids, FluorinatedSteroidsFused-Ring CompoundsPolycyclic CompoundsPregnadienetriolsPregnadienesPregnanes

Study Officials

  • Cesar W. Noce, DDS, MSD

    Universidade Federal do Rio de Janeiro

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2012

First Posted

October 3, 2012

Study Start

August 1, 2008

Primary Completion

July 1, 2012

Study Completion

August 1, 2012

Last Updated

October 3, 2012

Record last verified: 2012-09

Locations

BR(2)