A Randomized, Placebo-Controlled, Double-Blind Clinical Trial of Curcuminoids in Oral Lichen Planus

• Status: Terminated
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: National Institutes of Health (NIH)

Criteria

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.