Graft-Versus-Host Disease
A Randomized Double-Blind Pilot Study of Topical Clobetasol 0.05% Oral Rinse for Oral Chronic Graft-Versus-Host Disease
NCI-12-C-0068, NCT01557517
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Investigator(s): |
Steven Z. Pavletic, M.D., M.S.
Principal Investigator
Phone: 301-402-4899
Fax: 301-451-5578
pavletis@mail.nih.gov
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Kristen Cole, R.N., B.S.N., O.C.N.
Research Nurse Specialist
Phone: 301-451-6569
colekr@mail.nih.gov
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Zetta Blacklock, R.N., B.S., B.S.N.
Transplant Coordinator
Phone: 301-594-2056
Fax: 301-451-5578
bblacklock@mail.nih.gov
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Sheila Phang, R.N., M.S.
Phone: 301-435-9379
Fax: 301-451-5578
sphang@mail.nih.gov
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Key Eligibility Criteria:
- 12–99 years of age
- Diagnosis of clinically significant oral graft-versus-host disease (GVHD) after allogeneic HSCT, with a severity score of at least 2 on erythema subset and/or at least 1 on ulceration subset and a composite score > 20 of the Oral Mucositis Rating Scale
- Platelet count ≥ 20,000/μL at the time of the initial evaluation
- Able to rinse and spit out the study medication
- No use of clobetasol intra-orally within the past 6 weeks
- Able and willing to come to the Clinical Center at NIH for bi-weekly follow-up appointments
Study Outline:
This is a randomized, double blind, placebo-controlled, pilot study of clobetasol 0.05 percent topical oral rinse with an open label extension period.
- Screening with a physical examination, medical history, blood and urine tests
- Patients will rinse their mouth with clobetasol oral rinse or placebo (looks like clobetasol but contains no active ingredients) for 2 minutes 3 times a day
- Study treatment duration will be for 2 weeks in the randomized phase and 2–4 weeks in the open-label phase
- Follow up visits
Additional Information:
- This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
- There is no charge for medical care received at NIH Clinical Center.
- PDQ (Physicians Data Query) - provides additional details about this study for health care providers.
Reviewed: 9/6/12
Updated: 11/14/12
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