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

Primary Purpose

Oral Lichen Planus

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Curcuminoids

Placebo

About this trial

This is an interventional treatment trial for Oral Lichen Planus focused on measuring curcuminoids, oral lichen planus, c reactive protein, interleukin 6

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Curcumin

Placebo

Arm Description

Curcumin C3 Complex

Placebo

Outcomes

Primary Outcome Measures

Percent Change From Baseline to Two Weeks in Symptoms and Signs of Oral Lichen Planus (OLP)

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

Change in Serum C-reactive Protein and Serum Interleukin-6 Levels

Percentage changes from baseline to two weeks in C-Reactive protein (CLP) and interleukin-6 (IL-6).

Full Information

NCT ID

NCT00525421

First Posted

September 4, 2007

Last Updated

August 5, 2013

Sponsor

Nita Chainani Wu

1. Study Identification

Unique Protocol Identification Number

NCT00525421

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

February 2009 (Actual)

Study Completion Date

February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Nita Chainani Wu

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Oral Lichen Planus

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Curcumin

Arm Type

Experimental

Arm Description

Curcumin C3 Complex

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

Curcuminoids

Other Intervention Name(s)

Curcumin C3 Complex

Intervention Description

Curcuminoids tablets 2000mg three times per day for 12 days

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Percent Change From Baseline to Two Weeks in Symptoms and Signs of Oral Lichen Planus (OLP)

Description

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

Change in Serum C-reactive Protein and Serum Interleukin-6 Levels

Description

Percentage changes from baseline to two weeks in C-Reactive protein (CLP) and interleukin-6 (IL-6).

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nita Chainani-Wu, DMD, MS, PhD

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sol Jr. Silverman, MA, DDS

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California, San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

12676044

Citation

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.

Results Reference

background

PubMed Identifier

17604143

Citation

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.

Results Reference

background

PubMed Identifier

21907450

Citation

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.

Results Reference

result

Learn more about this trial

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

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