Status:
COMPLETED
Hydroxychloroquine vs. Clobetasol Rinse to Treat Oral Lichen Planus
Lead Sponsor:
National Institute of Dental and Craniofacial Research (NIDCR)
Conditions:
Lichen Planus, Oral
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
This study will compare two treatments for oral lichen planus - hydroxychloroquine (Plaquenil) tablets and clobetasol oral rinse. Oral lichen planus is a chronic disorder in which patients have painfu...
Detailed Description
This is a randomized double blind parallel group trial of safety and efficacy of hydroxychloroquine in oral lichen planus and associated cutaneous and genital lesions. The primary objective of the st...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Biopsy confirmed symptomatic erosive oral lichen planus. World Health Organization histological criteria (21) in combination with compatible clinical picture will be used for diagnosis. In questionable cases, direct immunofluorescence will be performed to exclude other conditions.
- No current treatment with hydroxychloroquine or other 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.
- Age greater than 18 years old. Lichen planus is very rare in patients younger than 40 years old and children are especially sensitive to the effects of hydroxychloroquine.
- Patients of both sexes and all racial and ethnic groups will be eligible.
- The presence of at least one ulcerated oral lesion with a surface area of at least 100 sq. mm as measured bi-directionally.
- EXCLUSION CRITERIA:
- Unable to undergo oral biopsy for diagnosis
- Lichen planus with no ulcerated oral lesions of greater than 100 sq. mm in area.
- Treatment with hydroxychloroquine or other immunomodulatory agents within 1 month of the randomization.
- Hepatitis B or Hepatitis C infection
- Significant abnormalities in hepatic status as measured by liver function tests (ALT, AST, AP, bilirubin.) Mild asymptomatic elevations in liver enzymes (up to 20% above the reference range) will not preclude enrollment in the trial.
- Significant abnormalities in renal status as measured by kidney function tests (creatinine, BUN).
- Uncontrolled diabetes
- Contraindications to hydroxychloroquine or clobetasol therapy (known hypersensitivity, retinopathy from prior use, history of aplastic anemia or agranulocytosis).
- Anemia (defined as a hemoglobin level more than 2 standard deviations below the mean reference value for age).
- Granulocytopenia (defined as an absolute neutrophil count (ANC) in adults as less than 1500/mm(3)).
- Pregnancy or lactation. Pregnancy status will be assessed by questionnaire. Potentially pregnant patients will be evaluated by plasma HCG test. Patients planning pregnancy will be excluded. Sexually active females will be required to use contraception prior to enrollment in the study. Every woman of childbearing age will have a pregnancy test.
- Inability or unwillingness to give written informed consent.
- Serious concurrent disease (e.g. myocardial infarction, severe heart failure, severe COPD) requiring hospitalization or limiting life expectancy to less than 1 year.
- Psoriasis
- G6PD deficiency
- Porphyria
- Chronic use of non-steroidal anti-inflammatory agents or other agents to relieve pain.
Exclusion
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00102557
Start Date
January 1 2005
End Date
October 1 2005
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