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

NCT ID: NCT00525421

Last Updated: 2013-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2009-02-28

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.

Conditions

Oral Lichen Planus

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Curcumin

Curcumin C3 Complex

Group Type: EXPERIMENTAL

Curcuminoids

Intervention Type: DRUG

Curcuminoids tablets 2000mg three times per day for 12 days

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Curcuminoids

Curcuminoids tablets 2000mg three times per day for 12 days

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

Curcumin C3 Complex

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nita Chainani Wu

OTHER

Sponsor Role: lead

Responsible Party

Nita Chainani Wu

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nita Chainani-Wu, DMD, MS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Sol Jr. Silverman, MA, DDS

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 12676044 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17604143 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21907450 (View on PubMed)

Other Identifiers

H1113-30233-01

Identifier Type: -

Identifier Source: org_study_id