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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Curcumin | Experimental | Curcumin C3 Complex |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curcuminoids | Drug | Curcuminoids tablets 2000mg three times per day for 12 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nita Chainani-Wu, DMD, MS, PhD | University of California, San Francisco | Principal Investigator |
| Sol Jr. Silverman, MA, DDS | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12676044 | Background | 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. | |
| 17604143 | Background | 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. |
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3 patients had elevated liver enzymes at baseline and were excluded prior to randomization
23 patients with symptomatic oral lichen planus (OLP) presenting to the oral medicine clinic at the University of California, San Francisco (UCSF) between October 2007 and November 2008 were screening for this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Curcuminoid | Curcuminoids : Curcuminoids tablets 2000mg three times per day for 12 days |
| FG001 | Placebo | Placebo : identical placebo tablets three times per day for 12 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Curcuminoid | Curcuminoids : Curcuminoids tablets 2000mg three times per day for 12 days |
| BG001 | Placebo | Placebo : identical placebo tablets three times per day for 12 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | percent change | 2 weeks |
|
2 weeks
Side effects were recorded using a 10-item questionnaire, complete blood cell count, and measurement of liver enzymes, aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase at the 2-week follow-up visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Curcuminoid | Curcuminoids : Curcuminoids tablets 2000mg three times per day for 12 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nita Chainani-Wu | University of California San Francisco | 415-476-2045 | nita.wu@ucsf.edu |
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| ID | Term |
|---|---|
| D017676 | Lichen Planus, Oral |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D008010 | Lichen Planus |
| D017512 | Lichenoid Eruptions |
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| ID | Term |
|---|---|
| D036381 | Diarylheptanoids |
| ID | Term |
|---|---|
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
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| Placebo | Drug |
|
| 21907450 | Result | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Symptom Score for OLP | Numerical Rating Scale (NRS): 0=No oral discomfort, 10=worst imaginable oral discomfort | Number | Participants |
|
| Presence of Oral Ulcerations | Number | Participants |
|
| Past medication for OLP | Subjects who used medications in the past for OLP | Number | Participants |
|
| OG000 |
| Curcuminoid |
Curcuminoids : Curcuminoids tablets 2000mg three times per day for 12 days |
| OG001 | Placebo | Placebo: Identical placebo tablets three times per day for 12 days |
|
|
| Secondary | 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). | Posted | Median | Inter-Quartile Range | Percent change | 2 weeks |
|
|
|
| 0 |
| 10 |
| 4 |
| 10 |
| EG001 | Placebo | Placebo: Identical placebo tablets three times per day for 12 days | 0 | 10 | 2 | 10 |
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Heartburn | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Elevated liver enzymes | Hepatobiliary disorders | Systematic Assessment | Liver enzymes (AST, ALT and alkaline phosphatase) assessed for change from normal baseline to abnormal at follow-up. ALT changed form 40 to 44, and from 59 to 64. |
|
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| D017444 |
| Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009930 |
| Organic Chemicals |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |