Status:
TERMINATED
A Randomized, Placebo-controlled, Double-blind Clinical Trial of Curcuminoids in Oral Lichen Planus
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Oral Lichen Planus
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether curcuminoids are effective in the treatment of oral lichen planus.
Detailed Description
Lichen planus is a chronic mucocutaneous, immunologic disease. It can affect the oral mucosa, causing changes that can range from white lace-like patterns on the mucosa, to red atrophic changes to the...
Eligibility Criteria
Inclusion
- Patients presenting to the UCSF oral medicine clinic with oral lichen planus confirmed by biopsy. Patients with either the atrophic or the erosive form of oral lichen planus were eligible.
- Study subjects had to have a symptom score between 3 to 8 at the time of entry into the study. (Range of scale: zero to ten, with zero being no symptoms and ten being the worst imaginable symptoms.)
- Eligible subjects had to have discontinued systemic and/or topical corticosteroids for at least two weeks before entry into the study.
Exclusion
- Pregnancy, lactation or unwillingness to use an effective method of contraception. An attempt was to be made to ascertain the date of the last menstrual period among eligible pre-menopausal women. If pregnancy could not be ruled out, a pregnancy test was to be provided to the women before enrollment into the study.
- Patients younger than 21 years of age.
- Patients who could not return for follow-up visits at one week, 4 weeks and 7 weeks after enrollment.
- Patients with a medical contraindication or refusal to take prednisone and or/fluconazole.
- Patients who had a medical contraindication to discontinuation of systemic corticosteroids (eg. those on long term corticosteroid therapy).
- Patients with a history of gastric / duodenal ulcers or gallstones.
- Patients with a history of liver disease.
- Patients on anticoagulants or antiplatelet medications.
- Patients undergoing orthodontic treatment.
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
End Date :
September 1 2004
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00226174
Start Date
February 1 2003
End Date
September 1 2004
Last Update
November 8 2023
Active Locations (1)
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1
University of California
San Francisco, California, United States, 94143