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

• ClinicalTrials.gov Identifier: NCT00525421
• Recruitment Status: Completed
• First Posted: September 5, 2007
• Results First Posted: August 7, 2013
• Last Update Posted: August 7, 2013
• Sponsor: Nita Chainani Wu
• Information provided by (Responsible Party): Nita Chainani Wu, University of California, San Francisco

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Oral Lichen Planus	Drug: Curcuminoids; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, 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
• Study Start Date: October 2007
• Actual Primary Completion Date: February 2009
• Actual Study Completion Date: February 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: Curcumin; Curcumin C3 Complex	Drug: Curcuminoids; Curcuminoids tablets 2000mg three times per day for 12 days; Other Name: Curcumin C3 Complex
Placebo Comparator: Placebo; Placebo	Drug: Placebo

Outcome Measures

Primary Outcome Measures :

1. Percent Change From Baseline to Two Weeks in Symptoms and Signs of Oral Lichen Planus (OLP) [ Time Frame: 2 weeks ]
   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.

Secondary Outcome Measures :

1. Change in Serum C-reactive Protein and Serum Interleukin-6 Levels [ Time Frame: 2 weeks ]
   Percentage changes from baseline to two weeks in C-Reactive protein (CLP) and interleukin-6 (IL-6).

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, California

University of California, San Francisco

San Francisco, California, United States, 94143

Sponsors and Collaborators

Nita Chainani Wu

Investigators

• 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

More Information

Publications of Results:

Chainani-Wu N, Madden E, Lozada-Nur F, Silverman S Jr. High-dose curcuminoids are efficacious in the reduction in symptoms and signs of oral lichen planus. J Am Acad Dermatol. 2012 May;66(5):752-60. doi: 10.1016/j.jaad.2011.04.022. Epub 2011 Sep 9.

Other Publications:

Chainani-Wu N. Safety and anti-inflammatory activity of curcumin: a component of tumeric (Curcuma longa). J Altern Complement Med. 2003 Feb;9(1):161-8. doi: 10.1089/107555303321223035.

Chainani-Wu N, Silverman S Jr, Reingold A, Bostrom A, Mc Culloch C, Lozada-Nur F, Weintraub J. A randomized, placebo-controlled, double-blind clinical trial of curcuminoids in oral lichen planus. Phytomedicine. 2007 Aug;14(7-8):437-46. doi: 10.1016/j.phymed.2007.05.003. Epub 2007 Jul 2.

• Responsible Party: Nita Chainani Wu, Principal Investigator, University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT00525421
• Other Study ID Numbers: H1113-30233-01
• First Posted: September 5, 2007
• Results First Posted: August 7, 2013
• Last Update Posted: August 7, 2013
• Last Verified: August 2013

Keywords provided by Nita Chainani Wu, University of California, San Francisco:

curcuminoids; oral lichen planus; c reactive protein; interleukin 6

Additional relevant MeSH terms:

Lichen Planus, Oral; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Mouth Diseases; Stomatognathic Diseases; Curcumin; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action