A Clinical Study of Curcuminoids in the Treatment of Oral Lichen Planus - Full Text View

Purpose

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	Intervention	Phase
Oral Lichen Planus	Drug: Curcuminoids Drug: Placebo	Phase II

ChemIDplus related topics:

Curcumin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Randomized, Placebo-Controlled, Double-Blind Trial of a Two Week Course of Curcuminoids in Oral Lichen Planus

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

Change in symptoms of oral lichen planus [ Time Frame: 2 weeks ]

Secondary Outcome Measures:

Change in clinical signs, occurrence of side-effects, change in serum C-reactive protein and serum interleukin-6 levels [ Time Frame: 2 weeks ]

Estimated Enrollment:	26
Study Start Date:	September 2007

Arms	Assigned Interventions
1: Experimental	Drug: Curcuminoids Curcuminoids tablets 2000mg three times per day for 12 days
2: Placebo Comparator	Drug: Placebo

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00525421

Contacts


Contact: Nita Chainani-Wu, DMD, MS, PhD	(415) 577-5647	nita.wu@ucsf.edu

Locations


United States, California
	University of California, San Francisco	Recruiting
	San Francisco, California, United States, 94143
	Contact: Nita Chainani-Wu, DMD, MS, PhD 415-577-5647 nita.wu@ucsf.edu

Sponsors and Collaborators

University of California, San Francisco

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:

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. Review.

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. Epub 2007 Jul 2.

Study ID Numbers:	H1113-30233-01
First Received:	September 4, 2007
Last Updated:	May 6, 2008
ClinicalTrials.gov Identifier:	NCT00525421
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by University of California, San Francisco:

curcuminoids

oral lichen planus

c reactive protein

interleukin 6

Study placed in the following topic categories:

Mouth Diseases

Lichen Planus

Exanthema

Curcumin

Skin Diseases

Oral lichen planus

Stomatognathic Diseases

Skin Diseases, Papulosquamous

Lichen Planus, Oral

Additional relevant MeSH terms:

Lichenoid Eruptions

ClinicalTrials.gov processed this record on September 22, 2008

Sponsored by:	University of California, San Francisco
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00525421