Trial · NCT03509675
Use of Topical NSAID to Reduce Pain in Oral Lichen Planus and Oral Lichenoid Lesions.
NCT03509675, Phase 2, Phase 3, Completed, University of Washington; results first posted 2020-05-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Use of Topical NSAID to Reduce Pain in Oral Lichen Planus and Oral Lichenoid Lesions. Trials, record NCT03509675. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03509675
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Use of Topical NSAID to Reduce Pain in Oral Lichen Planus and Oral Lichenoid Lesions.
- NCT number
- NCT03509675
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 23 participants, actual
- Lead sponsor
- University of Washington
- Conditions
- Oral Lichen Planus, Oral Lichenoid Mucositis, Oral Lichenoid Reaction
- Interventions
- Ibuprofen suspension 5mg/100ml, Placebos
- First posted
- 2018-04-26
- Last updated
- 2020-05-08
- Results first posted
- 2020-05-08
- Limitations and caveats
- Inadequate sample size may have prevented us from observing a significant pain reduction.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Self-reported Pain Scores Using 100m Visual Analog Scale 0-100 Pain Score. | 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Self-reported Pain Scores Using 100m Visual Analog Scale 0-100 Pain Score. | Total pain improvement over day 0 to day 7 (summation of improvement over 7 days) | mm | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Self-reported Pain Scores Using 100m Visual Analog Scale 0-100 Pain Score. | Placebo | 6.4 | Standard Deviation 15.3 | mm | |
| Self-reported Pain Scores Using 100m Visual Analog Scale 0-100 Pain Score. | Ibuprofen Rinse | 12.3 | Standard Deviation 23.4 | mm |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention (7 Days) | STARTED | Placebo First, Then Ibuprofen Rinse | 11 | |
| First Intervention (7 Days) | STARTED | Ibuprofen Rinse First, Then Placebo | 12 | |
| First Intervention (7 Days) | COMPLETED | Placebo First, Then Ibuprofen Rinse | 6 | |
| First Intervention (7 Days) | COMPLETED | Ibuprofen Rinse First, Then Placebo | 8 | |
| First Intervention (7 Days) | NOT COMPLETED | Placebo First, Then Ibuprofen Rinse | 5 | |
| First Intervention (7 Days) | NOT COMPLETED | Ibuprofen Rinse First, Then Placebo | 4 | |
| Washout Period (7 Days) | STARTED | Placebo First, Then Ibuprofen Rinse | 6 | |
| Washout Period (7 Days) | STARTED | Ibuprofen Rinse First, Then Placebo | 8 | |
| Washout Period (7 Days) | COMPLETED | Placebo First, Then Ibuprofen Rinse | 6 | |
| Washout Period (7 Days) | COMPLETED | Ibuprofen Rinse First, Then Placebo | 8 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 23 |
| Total, all-cause mortality | Active Ingredient | 0 | 23 |
| Total, other adverse events | Placebo | 0 | 23 |
| Total, other adverse events | Active Ingredient | 0 | 23 |
| Total, serious adverse events | Placebo | 0 | 23 |
| Total, serious adverse events | Active Ingredient | 0 | 23 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Active Ingredient vs Placebo: deaths from any cause | Trial comparisons |
| Active Ingredient vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03509675
GET https://conductscience.org/api/trials/v1/NCT03509675/registered