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Topical Dexamethasone and Tacrolimus for the Treatment of Oral Chronic Graft-Versus-Host Disease

Information source: Dana-Farber Cancer Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Oral Chronic Graft-versus-host Disease

Intervention: Tacrolimus (Drug); Dexamethasone (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Brigham and Women's Hospital

Official(s) and/or principal investigator(s):
Nathaniel Treister, DMD, Principal Investigator, Affiliation: Brigham and Women's Hospital

Summary

The purpose of this research study is to determine the effectiveness of topical steroid therapy (with a drug called dexamethasone) and topical tacrolimus therapy for the treatment of oral chronic Graft-Versus-Host Disease (cGVHD)

Clinical Details

Official title: An Open Label Phase II Randomized Trial of Topical Dexamethasone and Tacrolimus for the Treatment of Oral Chronic Graft-Versus-Host Disease

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The Clinical Efficacy of Topical Steroid and Topical Tacrolimus Therapies for the Treatment of Oral cGHVD.

Detailed description:

- Because no one knows which study option is best, participants will be "randomized" into

one of two study groups: topical dexamethasone or topical tacrolimus.

- Participants will take the medication by mouth rinse four times a day for 5 minutes at

a time. After rinsing they will spit out the medication and will not be able to eat or drink for 15 minutes.

- Participants will also take anti-fungal medication (fluconazole) orally once a week.

- After two weeks on study treatment, participants will have a blood drawn to monitor

tacrolimus levels.

- After the final treatment (4 weeks), participants will have the following tests and

procedures: clinical examination; questionnaire; blood tests; oral culture; optional tissue biopsy.

Eligibility

Minimum age: 4 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with oral chronic graft-versus-host disease

- Patients 4 years of age or older

- Stable cGVHD medication regimen for the four weeks prior to study enrollment

Exclusion Criteria:

- Patients already on topical steroid or tacrolimus therapies

Locations and Contacts

Beth-Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States

Brigham and Women's Hospital, Boston, Massachusetts 02115, United States

Children's Hospital Boston, Boston, Massachusetts 02115, United States

Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States

Massachusetts General Hospital, Boston, Massachusetts 02114, United States

Additional Information

Starting date: August 2008
Last updated: February 24, 2014

Page last updated: August 23, 2015

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