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A Randomized Double-Blind Pilot Study of Topical Clobetasol 0.05% Oral Rinse for Oral Chronic Graft-Versus-Host-Disease
Sponsor study identifier
Secondary identifiers
interventional
40
1 country
1
Study Start
March 28, 2012
Actual (reported)Primary Completion
June 9, 2017
Actual (reported)Study Completion
August 24, 2017
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 24, 2017
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 16, 2012
Actual (reported)March 19, 2012
Actual (reported)March 28, 2012
Actual (reported)June 9, 2017
Actual (reported)August 24, 2017
Actual (reported)January 3, 2019
Actual (reported)Percentage of Participants With a Response as Assessed by the 273-point Oral Mucositis Rating Scale (OMRS) Who Received Topical Clobetasol 0.05% Oral Rinse for Oral Chronic Graft-versus-host-disease (cGVHD) During a Four-week Treatment Period
Mucosal changes were assessed by the Oral Mucositis Rating Scale. The primary endpoint was evaluated using the OMRS. Oral tissue changes are rated on a scale of 0-3 compared with normal oral tissue (0-normal/no change, 1-mild change, 2-moderate change, and 3-severe change). Total score is the sum of all OMRS items with a possible range of 0. Total score is the sum of all OMRS items with a possible range of 0-273. Lower score=more normal oral mucosa. There is no standard definition of response in this field. Definitions we used in this pilot study to grade the response to study intervention are: Progress of 25% of initial score (rounded to the closest number) on the OMRS scale. Completion (PD) is defined as an increase of 25% of initial score (rounded to the closest number). Partial Response (PR) is defined as a decrease Response (CR) is defined as a PR plus a score of 0 on the erythema and ulceration components. Stable Disease (SD) does not meet criteria for progression or response.
At 4 weeks on active treatment
Percent Change in Participants' Raw Score of Oral cGVHD Related Pain on a 0-10 Rating Scale
Baseline to Day 14 and baseline to Day 28
Percent Change in Participants' Raw Score of Oral cGVHD Related Sensitivity on a 0-10 Rating Scale
Baseline and 4 weeks on active treatment
Percent Change in Participants' Raw Score of Oral cGVHD Related Dryness on a 0-10 Rating Scale
Baseline and 4 weeks on active treatment
Maximum Plasma Concentration (Cmax) of Clobetasol During Pharmacokinetic Testing
pre-rinse, 15-45 min post-rinse, and 90-120 min post-rinse
Plasma Concentrations of Clobetasol Mouth Rinse in cGVHD Patients at Baseline (Day 0) and Day 28
Baseline Day 0 and Day 28
Patients will rinse oral cavity with 10cc of clobetasol 0.05% for 2 minutes 3 times a day.
Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day.
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.
Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day.
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Imanguli MM, Pavletic SZ, Guadagnini JP, Brahim JS, Atkinson JC. Chronic graft versus host disease of oral mucosa: review of available therapies. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Feb;101(2):175-83. doi: 10.1016/j.tripleo.2005.08.028.
Pavletic SZ, Lee SJ, Socie G, Vogelsang G. Chronic graft-versus-host disease: implications of the National Institutes of Health consensus development project on criteria for clinical trials. Bone Marrow Transplant. 2006 Nov;38(10):645-51. doi: 10.1038/sj.bmt.1705490. Epub 2006 Sep 18.
Najla El Jurdi, M.D.
National Cancer Institute (NCI)
40 participants (actual enrollment reported by the registry).
First Submitted
March 16, 2012
First Posted
March 19, 2012
Study Start
March 28, 2012
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Flowers ME, Parker PM, Johnston LJ, Matos AV, Storer B, Bensinger WI, Storb R, Appelbaum FR, Forman SJ, Blume KG, Martin PJ. Comparison of chronic graft-versus-host disease after transplantation of peripheral blood stem cells versus bone marrow in allogeneic recipients: long-term follow-up of a randomized trial. Blood. 2002 Jul 15;100(2):415-9. doi: 10.1182/blood-2002-01-0011.
El Jurdi N, Leinbach LI, Curtis LM, Dodge JT, Schmidt KT, Yanovski JA, Costa-da-Silva AC, Peer CJ, Sharma R, Rose JJ, Cho MM, Jin H, Starling J, Avila DN, Masuch LR, Figg WD, Bassim CW, Kanakry CG, Hakim FT, Pavletic SZ, Mays JW. A randomized phase 2 placebo-controlled trial of clobetasol solution for oral chronic graft-versus-host disease therapy. Blood Adv. 2026 Sep 25:bloodadvances.2026020880. doi: 10.1182/bloodadvances.2026020880. Online ahead of print.
Primary Completion
June 9, 2017
Actual (reported)Study Completion
August 24, 2017
Actual (reported)Last Updated
June 15, 2025
Results First Posted
January 3, 2019
Record last verified: 2025-06
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Source: ClinicalTrials.gov.
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