A Randomized, Placebo-controlled, Double-blind Clinical Trial of Curcuminoids in Oral Lichen Planus

H1113-19156-03

The purpose of this study is to determine whether curcuminoids are effective in the treatment of oral lichen planus.

2003-02-01

2004-09-01

Terminated

Early phase I

-1

Inclusion Criteria: * 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 Criteria: * 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE'}}}

2023-11-08