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Dexamethasone to Treat Oral Lichen Planus

NCT00111072 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2008-03-04

No results posted yet for this study

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.

Conditions

  • Oral Lichen Planus

Interventions

DRUG

dexamethasone 0.01% solution

Sponsors & Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

    lead NIH

Study Design

Purpose
TREATMENT

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Completion
2006-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00111072 on ClinicalTrials.gov