Dexamethasone to Treat Oral Lichen Planus

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Dental and Craniofacial Research (NIDCR)
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Pharmaceutical Solutions

Criteria

INCLUSION CRITERIA:

Biopsy confirmed symptomatic oral lichen planus. World Health Organization histological criteria (12) in combination with a compatible clinical appearance will be used for diagnosis.

No current treatment with immunomodulatory agents. A one-month washout period will be required prior to enrollment if patients are taking immunomodulatory agents. Prior treatment with topical steroids will be allowed provided the presence of symptomatic lesions.

Age greater than 12 years old. Lichen planus is very rare in patients younger than 40 years old. Patients must rinse and spit the medication rather than swallow it. Oral rinses such as topical fluorides are not recommended for young children.

Patients of both sexes and all racial and ethnic groups will be eligible.

Symptomatic lichen planus with a score of at least 35 mm on a visual analog scale for pain.

Oral lichen planus score of at least 3 on the lichen planus severity scale.

EXCLUSION CRITERIA:

Unable to undergo oral biopsy for diagnosis.

Asymptomatic lichen planus with no ulcerated or erythematous oral lesions.

Treatment with immunomodulatory agents within 1 month of the randomization.

Hepatitis C infection.

Documented hypersensitivity to dexamethasone.

Pregnancy or lactation.

Poorly controlled diabetes.

Inability or unwillingness to give written informed consent.