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Clobetasol for Oral Graft-Versus-Host Disease

NCT01557517 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-06-15

Study results available
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Summary

Background:

\- Oral graft-versus-host disease (GVHD) is a possible complication of bone marrow transplants. It is the result of the donor cells trying to attack the recipients body. Symptoms include dry mouth, sensitivity and pain when tasting certain spices and flavors, and painful swallowing. Steroids are a possible effective treatment for GHVD, but they can cause side effects when given as pills or injections. Steroids given in a cream or rinse form, applied directly to the site of the symptoms, can have fewer side effects. However, their effectiveness as a rinse has not been tested in the mouth. Researchers want to see if a steroid called clobetasol can be used as a mouth rinse to treat oral GHVD.

Objectives:

\- To see if a clobetasol rinse is a safe and effective treatment for oral graft-versus-host disease.

Eligibility:

\- Individuals at least 12 years of age who have oral GHVD and are not allergic to clobetasol.

Design:

* Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. They will also have an oral exam, a mouth tissue biopsy, and other tests before starting the study drug.
* Participants will be separated into two groups. One group will receive clobetasol; the other will have a placebo liquid.
* Participants will rinse their mouths with the study liquid three times a day after meals for 2 weeks.
* After 2 weeks, participants will have another study visit with blood tests and other exams.
* After the study visit, all participants will start to use the clobetasol rinse. Those who originally had clobetasol will use the rinse for another 2 weeks. Those who originally had a placebo will use the rinse for 4 weeks.
* Participants will have a follow-up exam after the end of treatment....

Conditions

  • Oral Chronic Graft vs Host Disease

Interventions

DRUG

Clobetasol Oral Rinse

Cycle= up to 4 weeks Patients will rinse oral cavity with 10cc of clobetasol 0.05% oral rinse for 2 minutes 3 times a day.

DRUG

Placebo oral rinse

Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Najla El Jurdi, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-28
Primary Completion
2017-06-09
Completion
2017-08-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT01557517 on ClinicalTrials.gov