This study will evaluate the effectiveness of dexamethasone 0.01% solution in treating pain
associated with oral lichen planus, a chronic disease that causes painful ulcers inside the
mouth. The cause of lichen planus not known, but it may be related to an allergic or immune
reaction. This study will examine what causes the disease, the pain associated with it, its
impact on patients' lives and the use of dexamethasone to treat it.
Patients 12 or older with severe oral lichen planus may be eligible for this study.
Candidates are screened with blood tests and a biopsy to confirm the diagnosis and provide
tissues for research purposes. For the biopsy, two small circles of tissue, each about 4 mm
(1/5 inch) across, are surgically removed.
Participants are randomly assigned to rinse their mouth with either a dexamethasone solution
or placebo (a rinse with no active ingredient) four times a day for 4 weeks. During this
period they may not use any oral or topical pain or anti-inflammatory medications except
diphenhydramine 12.5 mg/5 ml (a topical numbing medicine) and Tylenol, both which are
provided by the study.
Patients come to the NIH Clinical Center for three 1-hour visits (once every two weeks) and
once more 4 weeks after the study medications are stopped. At the first three visits patients
submit a pain diary in which they have recorded information on pain levels, and they are
checked for any medication side effects. On the third visit (the last day they take the study
drug) they are also tested for adrenal suppression that may have resulted from taking the
steroid rinse. For this test they are given an injection of a drug called synacthen and after
1 hour, a blood sample is drawn. Patients return for a final visit 1 month later to determine
if their disease returns or improves after the medication is stopped.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Dental and Craniofacial Research (NIDCR)