A Clinical Study of Curcuminoids in the Treatment of Oral Lichen Planus

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

A phase 2 randomized, placebo-controlled, double-blind trial of a two week course of curcuminoids in oral lichen planus will be conducted. 26 consecutive, eligible patients with OLP presenting to the oral medicine clinic at the University of California, San Francisco, will be enrolled. Study subjects will be randomized to receive either placebo or curcuminoids 6000mg/day for 2 weeks in three divided doses of 2000mg three times/day. Measurement of signs, symptoms, periodontal status and blood tests including complete blood count, liver enzymes, serum c reactive protein and serum interleukin-6 levels will be done at baseline and at the end of 2 weeks. A side-effects questionnaire will be administered at the 2-week follow-up.

The Numeric Rating Scale (NRS) will be used to measure symptoms and the Modified Oral Mucositis Index (MOMI) to measure clinical signs of OLP. Primary outcome is change in symptoms from baseline. Secondary outcomes are change in clinical signs, occurrence of side-effects, change in serum C-reactive protein and serum interleukin-6 levels.

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

Details

• Lead Sponsor: Nita Chainani Wu
• Treatments: Curcumin

Criteria

Inclusion Criteria:

• Patients presenting to the UCSF oral medicine clinic diagnosed with either the atrophic or the erosive form of oral lichen planus

• Study subjects must 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.

• Study subjects will have discontinued systemic and/or topical steroids and/or curcuminoids for at least 2 weeks before entry into the study.

Exclusion Criteria:

• Pregnancy, lactation or unwillingness to use an effective method of contraception. An attempt will be made to ascertain the date of the last menstrual period among eligible pre-menopausal women. If pregnancy cannot be ruled out, a pregnancy test will be provided to the women before enrollment into the study. - Patients younger than 21 years of age.

• Patients who cannot return for a follow-up visit at two weeks after enrollment.

• Patients who have a medical contraindication to discontinuation of systemic steroids eg. those on long term corticosteroid therapy. - Patients with a history of gastro-esophageal reflux disease, gastric / duodenal ulcers, or gallstones.

• Patients with elevated liver enzymes;

• Patients on anticoagulants or antiplatelet medications.

• Patients undergoing orthodontic treatment.

• Patients who don't read, speak or understand English.