Status:
COMPLETED
Dexamethasone to Treat Oral Lichen Planus
Lead Sponsor:
National Institute of Dental and Craniofacial Research (NIDCR)
Conditions:
Oral Lichen Planus
Eligibility:
All Genders
Phase:
PHASE2
Brief 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...
Detailed Description
This is a study of pain, oral function and salivary biomarkers in oral lichen planus. The primary objective of the study is to determine the efficacy of dexamethasone rinse in reducing pain in patien...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00111072
Start Date
May 1 2005
End Date
March 1 2006
Last Update
March 4 2008
Active Locations (1)
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1
National Institute of Dental And Craniofacial Research (NIDCR)
Bethesda, Maryland, United States, 20892