Trial Outcomes & Findings for Use of Topical NSAID to Reduce Pain in Oral Lichen Planus and Oral Lichenoid Lesions. (NCT NCT03509675)
NCT ID: NCT03509675
Last Updated: 2020-05-08
Results Overview
We will be looking for an improvement in symptoms through summation of the reduction in pain using a 100mm, where 0= no pain and 100= worst pain experienced Visual Analog Scale(VAS). Minimum pain level of 30mm out of 100 mm was an inclusion criteria in the study. Participants were asked to record spontaneous pain level at day 0, day 4 and at the end of day 7 timepoints for both arms/groups. Lower scores mean a better outcome.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
23 participants
Primary outcome timeframe
Total pain improvement over day 0 to day 7 (summation of improvement over 7 days)
Results posted on
2020-05-08
Participant Flow
The recruitment started in April 2018 and ended on Jan 30, 2019. All subjects were asked to join the trial at Oral Medicine Clinical Services at the University of Washington.
Participant milestones
| Measure |
Placebo First, Then Ibuprofen Rinse
Subjects were asked to rinse 4 times per day with 5ml of placebo rinse. Self-reported pain scores were recorded using a 100mm VAS pain scale at timepoints Day 0, Day 4 and Day 7.
A seven day washout period was used after the placebo rinse, before commencing the ibuprofen rinse.
Placebos: Placebo
|
Ibuprofen Rinse First, Then Placebo
Subjects were asked to rinse 4 times per day with 5ml of ibuprofen suspension (5mg/100ml) as a rinse. Self-reported pain scores were recorded using a 100mm VAS pain scale at timepoints Day 0, Day 4 and Day 7.
A seven day washout period was used after the ibuprofen rinse, before commencing the placebo rinse.
Non-Steroidal Anti-inflammatory Topical Rinse: Non-Steroidal Anti-inflammatory Topical Rinse will be used for Symptomatic OLP patients.
|
|---|---|---|
|
First Intervention (7 Days)
STARTED
|
11
|
12
|
|
First Intervention (7 Days)
COMPLETED
|
6
|
8
|
|
First Intervention (7 Days)
NOT COMPLETED
|
5
|
4
|
|
Washout Period (7 Days)
STARTED
|
6
|
8
|
|
Washout Period (7 Days)
COMPLETED
|
6
|
8
|
|
Washout Period (7 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention )7 Days)
STARTED
|
6
|
8
|
|
Second Intervention )7 Days)
COMPLETED
|
4
|
8
|
|
Second Intervention )7 Days)
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Placebo First, Then Ibuprofen Rinse
Subjects were asked to rinse 4 times per day with 5ml of placebo rinse. Self-reported pain scores were recorded using a 100mm VAS pain scale at timepoints Day 0, Day 4 and Day 7.
A seven day washout period was used after the placebo rinse, before commencing the ibuprofen rinse.
Placebos: Placebo
|
Ibuprofen Rinse First, Then Placebo
Subjects were asked to rinse 4 times per day with 5ml of ibuprofen suspension (5mg/100ml) as a rinse. Self-reported pain scores were recorded using a 100mm VAS pain scale at timepoints Day 0, Day 4 and Day 7.
A seven day washout period was used after the ibuprofen rinse, before commencing the placebo rinse.
Non-Steroidal Anti-inflammatory Topical Rinse: Non-Steroidal Anti-inflammatory Topical Rinse will be used for Symptomatic OLP patients.
|
|---|---|---|
|
First Intervention (7 Days)
Lost to Follow-up
|
3
|
3
|
|
First Intervention (7 Days)
Lack of Efficacy
|
2
|
1
|
|
Second Intervention )7 Days)
Withdrawal by Subject
|
1
|
0
|
|
Second Intervention )7 Days)
Lost Rinse B
|
1
|
0
|
Baseline Characteristics
Use of Topical NSAID to Reduce Pain in Oral Lichen Planus and Oral Lichenoid Lesions.
Baseline characteristics by cohort
| Measure |
Placebo First, Then Ibuprofen Rinse
n=11 Participants
Placebo suspension was compounded with the same taste as the active medication but without the active ingredient.
Placebos: Placebo
|
Ibuprofen Rinse First, Then Placebo
n=12 Participants
The topical suspension of the topical NSAID was 100 mg per 5 ml concentration of ibuprofen, with similar ingredients as OTC children's ibuprofen and was compounded by an external drug service.
Non-Steroidal Anti-inflammatory Topical Rinse: Non-Steroidal Anti-inflammatory Topical Rinse will be used for Symptomatic OLP patients.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Continuous
|
66.9 years
STANDARD_DEVIATION 33.0 • n=5 Participants
|
66.9 years
STANDARD_DEVIATION 33.0 • n=7 Participants
|
66.9 years
STANDARD_DEVIATION 33.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Baseline Pain
|
55.9 units on a scale
STANDARD_DEVIATION 19.2 • n=5 Participants
|
50.8 units on a scale
STANDARD_DEVIATION 16.6 • n=7 Participants
|
53.2 units on a scale
STANDARD_DEVIATION 17.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: Total pain improvement over day 0 to day 7 (summation of improvement over 7 days)We will be looking for an improvement in symptoms through summation of the reduction in pain using a 100mm, where 0= no pain and 100= worst pain experienced Visual Analog Scale(VAS). Minimum pain level of 30mm out of 100 mm was an inclusion criteria in the study. Participants were asked to record spontaneous pain level at day 0, day 4 and at the end of day 7 timepoints for both arms/groups. Lower scores mean a better outcome.
Outcome measures
| Measure |
Placebo
n=23 Participants
Placebo suspension was compounded with the same taste as the active medication but without the active ingredient.
Placebos: Placebo
|
Ibuprofen Rinse
n=23 Participants
The topical suspension of the topical NSAID was 100 mg per 5 ml concentration of ibuprofen, with similar ingredients as OTC children's ibuprofen and was compounded by an external drug service.
Non-Steroidal Anti-inflammatory Topical Rinse: Non-Steroidal Anti-inflammatory Topical Rinse will be used for Symptomatic OLP patients.
|
|---|---|---|
|
Self-reported Pain Scores Using 100m Visual Analog Scale 0-100 Pain Score.
|
6.4 mm
Standard Deviation 15.3
|
12.3 mm
Standard Deviation 23.4
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Ingredient
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place