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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 (Responsible Party):
Nita Chainani Wu, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00525421
First received: September 4, 2007
Last updated: August 5, 2013
Last verified: August 2013
September 4, 2007
August 5, 2013
October 2007
February 2009   (Final data collection date for primary outcome measure)
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.
Change in symptoms of oral lichen planus [ Time Frame: 2 weeks ]
Complete list of historical versions of study NCT00525421 on ClinicalTrials.gov Archive Site
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).
Change in clinical signs, occurrence of side-effects, change in serum C-reactive protein and serum interleukin-6 levels [ Time Frame: 2 weeks ]
Not Provided
Not Provided
 
A Clinical Study of Curcuminoids in the Treatment of Oral Lichen Planus
A Randomized, Placebo-Controlled, Double-Blind Trial of a Two Week Course of Curcuminoids in 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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Oral Lichen Planus
  • Drug: Curcuminoids
    Curcuminoids tablets 2000mg three times per day for 12 days
    Other Name: Curcumin C3 Complex
  • Drug: Placebo
  • Experimental: Curcumin
    Curcumin C3 Complex
    Intervention: Drug: Curcuminoids
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
February 2009
February 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00525421
H1113-30233-01
No
Not Provided
Not Provided
Nita Chainani Wu, University of California, San Francisco
Nita Chainani Wu
Not Provided
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
University of California, San Francisco
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP