Trial Outcomes & Findings for A Clinical Study of Curcuminoids in the Treatment of Oral Lichen Planus (NCT NCT00525421)
NCT ID: NCT00525421
Last Updated: 2013-08-07
Results Overview
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.
COMPLETED
PHASE2
20 participants
2 weeks
2013-08-07
Participant Flow
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.
3 patients had elevated liver enzymes at baseline and were excluded prior to randomization
Participant milestones
| Measure |
Curcuminoid
Curcuminoids : Curcuminoids tablets 2000mg three times per day for 12 days
|
Placebo
Placebo : identical placebo tablets three times per day for 12 days
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Study of Curcuminoids in the Treatment of Oral Lichen Planus
Baseline characteristics by cohort
| Measure |
Curcuminoid
n=10 Participants
Curcuminoids : Curcuminoids tablets 2000mg three times per day for 12 days
|
Placebo
n=10 Participants
Placebo : identical placebo tablets three times per day for 12 days
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
56.2 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
60.8 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
58.5 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Symptom Score for OLP
NRS 3-5
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Symptom Score for OLP
NRS 5.5-8
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Presence of Oral Ulcerations
Ulcerations at Baseline
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Presence of Oral Ulcerations
No Ulcerations at Baseline
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Past medication for OLP
Topical Steroids
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Past medication for OLP
No Topical Steroids
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Past medication for OLP
Prednisone
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Past medication for OLP
No Prednisone
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Past medication for OLP
Azathioprine
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Past medication for OLP
No Azathioprine
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Past medication for OLP
Any Prior Medication for OLP
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Past medication for OLP
No Prior Medication for OLP
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeksNumeric 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.
Outcome measures
| Measure |
Curcuminoid
n=10 Participants
Curcuminoids : Curcuminoids tablets 2000mg three times per day for 12 days
|
Placebo
n=10 Participants
Placebo: Identical placebo tablets three times per day for 12 days
|
|---|---|---|
|
Percent Change From Baseline to Two Weeks in Symptoms and Signs of Oral Lichen Planus (OLP)
NRS
|
-22 percent change
Interval -33.0 to -14.0
|
0 percent change
Interval -29.0 to 16.7
|
|
Percent Change From Baseline to Two Weeks in Symptoms and Signs of Oral Lichen Planus (OLP)
Erythema
|
-17 percent change
Interval -29.0 to -8.3
|
0 percent change
Interval -10.0 to 16.7
|
|
Percent Change From Baseline to Two Weeks in Symptoms and Signs of Oral Lichen Planus (OLP)
Ulceration
|
-14 percent change
Interval -60.0 to 0.0
|
0 percent change
Interval 0.0 to 26.7
|
|
Percent Change From Baseline to Two Weeks in Symptoms and Signs of Oral Lichen Planus (OLP)
MOMI
|
-24 percent change
Interval -38.0 to -11.0
|
-3.2 percent change
Interval -13.0 to 9.09
|
SECONDARY outcome
Timeframe: 2 weeksPercentage changes from baseline to two weeks in C-Reactive protein (CLP) and interleukin-6 (IL-6).
Outcome measures
| Measure |
Curcuminoid
n=10 Participants
Curcuminoids : Curcuminoids tablets 2000mg three times per day for 12 days
|
Placebo
n=10 Participants
Placebo: Identical placebo tablets three times per day for 12 days
|
|---|---|---|
|
Change in Serum C-reactive Protein and Serum Interleukin-6 Levels
IL-6
|
20.3 Percent change
Interval -16.0 to 60.6
|
-1.6 Percent change
Interval -6.1 to 3.17
|
|
Change in Serum C-reactive Protein and Serum Interleukin-6 Levels
CRP
|
0 Percent change
Interval -21.0 to 19.0
|
33.3 Percent change
Interval 0.0 to 50.0
|
Adverse Events
Curcuminoid
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Curcuminoid
n=10 participants at risk
Curcuminoids : Curcuminoids tablets 2000mg three times per day for 12 days
|
Placebo
n=10 participants at risk
Placebo: Identical placebo tablets three times per day for 12 days
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
2/10 • Number of events 2 • 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
|
10.0%
1/10 • Number of events 1 • 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
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • Number of events 1 • 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
|
10.0%
1/10 • Number of events 1 • 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
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • Number of events 1 • 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
|
0.00%
0/10 • 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
|
|
Gastrointestinal disorders
Heartburn
|
10.0%
1/10 • Number of events 1 • 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
|
0.00%
0/10 • 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
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • Number of events 1 • 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
|
0.00%
0/10 • 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
|
|
Hepatobiliary disorders
Elevated liver enzymes
|
20.0%
2/10 • Number of events 2 • 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
|
0.00%
0/10 • 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
|
Additional Information
Nita Chainani-Wu
University of California San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place