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

NCT01699412 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2012-10-03

No results posted yet for this study

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.

Conditions

  • Graft vs Host Disease
  • Oral Manifestations

Interventions

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

Sponsors & Collaborators

  • Grupo de Estudos Multicentricos em Onco-Hematologia

    lead NETWORK

Principal Investigators

  • Cesar W. Noce, DDS, MSD · Universidade Federal do Rio de Janeiro

  • Sandra R. Torres, DDS,MSD,PhD · Universidade Federal do Rio de Janeiro

  • Ângelo Maiolino, MD,MSD,PhD · Universidade Federal do Rio de Janeiro

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2012-07-31
Completion
2012-08-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01699412 on ClinicalTrials.gov