Oral Lichen Planus
Conditions
Keywords
curcuminoids, oral lichen planus, c reactive protein, interleukin 6
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.
Interventions
DRUGCurcuminoids
Curcuminoids tablets 2000mg three times per day for 12 days
DRUGPlacebo
Sponsors
Nita Chainani Wu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline to Two Weeks in Symptoms and Signs of Oral Lichen Planus (OLP) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum C-reactive Protein and Serum Interleukin-6 Levels | 2 weeks | Percentage changes from baseline to two weeks in C-Reactive protein (CLP) and interleukin-6 (IL-6). |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
3 patients had elevated liver enzymes at baseline and were excluded prior to randomization
Participants by arm
| Arm | Count |
|---|---|
| Curcuminoid Curcuminoids : Curcuminoids tablets 2000mg three times per day for 12 days | 10 |
| Placebo Placebo : identical placebo tablets three times per day for 12 days | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Placebo | Total | Curcuminoid |
|---|---|---|---|
| Age Continuous | 60.8 years STANDARD_DEVIATION 8.6 | 58.5 years STANDARD_DEVIATION 10.1 | 56.2 years STANDARD_DEVIATION 11.7 |
| Past medication for OLP Any Prior Medication for OLP | 8 Participants | 17 Participants | 9 Participants |
| Past medication for OLP Azathioprine | 1 Participants | 2 Participants | 1 Participants |
| Past medication for OLP No Azathioprine | 9 Participants | 18 Participants | 9 Participants |
| Past medication for OLP No Prednisone | 5 Participants | 9 Participants | 4 Participants |
| Past medication for OLP No Prior Medication for OLP | 2 Participants | 3 Participants | 1 Participants |
| Past medication for OLP No Topical Steroids | 3 Participants | 5 Participants | 2 Participants |
| Past medication for OLP Prednisone | 5 Participants | 11 Participants | 6 Participants |
| Past medication for OLP Topical Steroids | 7 Participants | 15 Participants | 8 Participants |
| Presence of Oral Ulcerations No Ulcerations at Baseline | 6 Participants | 13 Participants | 7 Participants |
| Presence of Oral Ulcerations Ulcerations at Baseline | 4 Participants | 7 Participants | 3 Participants |
| Region of Enrollment United States | 10 participants | 20 participants | 10 participants |
| Sex: Female, Male Female | 5 Participants | 13 Participants | 8 Participants |
| Sex: Female, Male Male | 5 Participants | 7 Participants | 2 Participants |
| Symptom Score for OLP NRS 3-5 | 6 Participants | 11 Participants | 5 Participants |
| Symptom Score for OLP NRS 5.5-8 | 4 Participants | 9 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 10 | 2 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
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.
Time frame: 2 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Curcuminoid | Percent Change From Baseline to Two Weeks in Symptoms and Signs of Oral Lichen Planus (OLP) | NRS | -22 percent change |
| Curcuminoid | Percent Change From Baseline to Two Weeks in Symptoms and Signs of Oral Lichen Planus (OLP) | Erythema | -17 percent change |
| Curcuminoid | Percent Change From Baseline to Two Weeks in Symptoms and Signs of Oral Lichen Planus (OLP) | Ulceration | -14 percent change |
| Curcuminoid | Percent Change From Baseline to Two Weeks in Symptoms and Signs of Oral Lichen Planus (OLP) | MOMI | -24 percent change |
| Placebo | Percent Change From Baseline to Two Weeks in Symptoms and Signs of Oral Lichen Planus (OLP) | MOMI | -3.2 percent change |
| Placebo | Percent Change From Baseline to Two Weeks in Symptoms and Signs of Oral Lichen Planus (OLP) | NRS | 0 percent change |
| Placebo | Percent Change From Baseline to Two Weeks in Symptoms and Signs of Oral Lichen Planus (OLP) | Ulceration | 0 percent change |
| Placebo | Percent Change From Baseline to Two Weeks in Symptoms and Signs of Oral Lichen Planus (OLP) | Erythema | 0 percent change |
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).
Time frame: 2 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Curcuminoid | Change in Serum C-reactive Protein and Serum Interleukin-6 Levels | IL-6 | 20.3 Percent change |
| Curcuminoid | Change in Serum C-reactive Protein and Serum Interleukin-6 Levels | CRP | 0 Percent change |
| Placebo | Change in Serum C-reactive Protein and Serum Interleukin-6 Levels | CRP | 33.3 Percent change |
| Placebo | Change in Serum C-reactive Protein and Serum Interleukin-6 Levels | IL-6 | -1.6 Percent change |