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

This study has been completed.
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00525421
First received: September 4, 2007
Last updated: March 2, 2009
Last verified: February 2009
History of Changes
  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 2

Study Type: Interventional
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

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
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Curcuminoids
Curcuminoids tablets 2000mg three times per day for 12 days
Other Name: Curcumin C3 Complex
Placebo Comparator: 2 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

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
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:

ClinicalTrials.gov Identifier: NCT00525421     History of Changes
Other Study ID Numbers: H1113-30233-01
Study First Received: September 4, 2007
Last Updated: March 2, 2009
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

Additional relevant MeSH terms:
Lichen Planus
Lichen Planus, Oral
Lichenoid Eruptions
Skin Diseases, Papulosquamous
 Skin Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 22, 2013