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Protocol Details

A Randomized Double-Blind Pilot Study of Topical Clobetasol 0.05% Oral rinse for Oral Chronic Graft-Versus-Host Disease

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 12
Max Age: N/A

Referral Letter Required


Population Exclusion(s)



Oral cGVHD;
Oral Rinse;

Recruitment Keyword(s)



Oral Chronic Graft vs Host Disease

Investigational Drug(s)


Investigational Device(s)



Drug: Clobetasol Oral Rinse
Drug: Placebo oral rinse

Supporting Site

National Cancer Institute


- 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 recipient s 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.


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


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


- 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.

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- Age: 12 years 99 years.

- Diagnosis: clinically significant oral cGVHD after allogeneic HSCT with severity score of at least 2 on erythema subset and/or at least 1 on ulceration subset and a composite score greater than or equal to 20 of the Oral Mucositis Rating Scale (OMRS) scale confirmed by the principal investigator (PI), clinical study chair (CSC), or lead associate investigator (LAI).

- Hematologic Function: Patients must have a platelet count greater than or equal to 20,000/microL at the time of the initial evaluation.

- Informed Consent: All patients or their legal representative (for patients <18 years old) must sign an IRB approved informed consent document (cGVHD natural history protocol 04-C-0281 or any NCI protocol allowing for screening procedures) prior to performing studies to determine patient eligibility. After confirmation of patient eligibility all patients or their legal representative must sign the protocol specific informed consent. For pediatric patients age appropriate assent will be obtained in accordance with NIH guidelines.

- Patients must be able to rinse and expectorate study medication rather than swallow it. Female patients must be willing to practice birth control (including abstinence) during and for two months after treatment, if of childbearing potential.

- Patients must have the ability and willingness to come to Clinical Center for bi-weekly follow-up appointments.

- No change in systemic immunosuppressive therapy (type or intensity level) within 2 weeks prior to enrollment.

- A 7-day washout period is required if patients are currently using another oral topical treatment for mouth lesions. Patients currently using clobetasol oral topical treatment are not eligible for this study.


- Documented hypersensitivity to clobetasol.

- Use of clobetasol ointment intra-orally at any time during the last 6-month period.

- Pregnant or breast-feeding females due to possible toxicity to the fetus or infant.

- Inability to understand the investigational nature of the study to provide informed consent.

- Patients who, for medical or other reasons, are unable to comply with the study procedures.

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Not Provided

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Principal Investigator

Referral Contact

For more information:

Steven Z. Pavletic, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 4-3130
(240) 760-6174

Steven Z. Pavletic, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 4-3130
(240) 760-6174

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office

Clinical Trials Number:


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