A Clinical Study of Curcuminoids in the Treatment of Oral Lichen Planus
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Placebo-Controlled, Double-Blind Trial of a Two Week Course of Curcuminoids in Oral Lichen Planus|
- Percent Change From Baseline to Two Weeks in Symptoms and Signs of Oral Lichen Planus (OLP) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]Numeric Rating Scale (NRS) is patient-reported numerical score for intensity of symptoms (range 0-10, where 0=no oral discomfort and 10=worst imaginable oral discomfort; symptom score over the last 1 week was recorded at baseline, and symptom score since baseline was recorded at follow-up. For Modified Oral Mucositis Index (MOMI) each of 16 oral sites is scored by an examiner for both erythema intensity (range 0-3 where 0=normal, 1=mild, 2=moderate, 3=severe) and area of ulceration (range 0-3 where 0=none, 1=>0-0.25 cm^2, 2= >0.25-1 cm^2, 3=>=1cm^2): right (R) and left (L) buccal mucosa, labial mucosa (upper and lower), lateral tongue (R and L), dorsum of tongue (R and L), ventral tongue and floor of mouth (R and L), maxillary gingiva (R and L), mandibular gingiva (R and L), and soft and hard palate. Total score for clinical signs (MOMI) is the sum of scores for 16 sites; separate scores for erythema and ulceration are the sums of respective scores.
- Change in Serum C-reactive Protein and Serum Interleukin-6 Levels [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]Percentage changes from baseline to two weeks in C-Reactive protein (CLP) and interleukin-6 (IL-6).
|Study Start Date:||October 2007|
|Study Completion Date:||February 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
Curcumin C3 Complex
Curcuminoids tablets 2000mg three times per day for 12 days
Other Name: Curcumin C3 Complex
Placebo Comparator: Placebo
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Nita Chainani-Wu, DMD, MS, PhD||University of California, San Francisco|
|Principal Investigator:||Sol Jr. Silverman, MA, DDS||University of California, San Francisco|