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NCT03509675 · ClinicalTrials.gov registry record · Phase 2
Use of Topical NSAID to Reduce Pain in Oral Lichen Planus and Oral Lichenoid Lesions.
A Phase 2 study of Oral Lichen Planus and Oral Lichenoid Mucositis, sponsored by University of Washington.
- Completed
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
- 1
- Study location
NCT03509675 is a Phase 2 study of Oral Lichen Planus and Oral Lichenoid Mucositis that has completed, run by University of Washington. The registered enrollment target is 23 participants, above the 18-participant average among 3 other Oral Lichen Planus trials with a reported enrollment target (28% higher). The trial reports 1 study location across 1 state.
The verdict
NCT03509675, a Phase 2 study of Oral Lichen Planus and Oral Lichenoid Mucositis, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
- 1
- Study location
Study Summary
Oral lichen planus (OLP) is a common chronic autoimmune disease associated with cell-mediated immunological dysfunction. Symptomatic OLP is painful and complete healing is rare. Current treatments for lichen planus and lichenoid mucositis are usually directed towards reducing the symptoms. This double-blinded cross-over placebo-controlled clinical trial is designed to measure the effectiveness of a topical NSAID (Ibuprofen suspension - 100mg/5ml) compared with a placebo in reducing pain associated with Oral Lichen Planus and Oral Lichenoid Lesions. Exclusion criteria include: * The occurrence of dysplasia in the histopathological specimen * Known or suspected sensitivity to NSAID medication * History of asthma * History of gastrointestinal ulceration * History of bleeding disorders * Pregnancy Outcome measures are self-reported pain scores at day 0, day 4 and day 7 of use of the placebo or active suspension, using a horizontal 100 mm, visual analog scale (VAS). If subjects were already on active treatment at the time of enrollment, they will be asked to discontinue for 7 days for a washout period before starting the research study. cord their spontaneous pain level on a 0-10 VAS. Participants will be contacted initially after the first day of the intervention to discuss any concerns or questions. Every week, reminder phone calls will be made to the subjects to fill out the forms from the investigator and to check for any side effects from the intervention. Both the patient and the investigator will be blinded for the content of each bottle.
Conditions Studied
Interventions
- DRUG Placebos
- DRUG Ibuprofen suspension 5mg/100ml
Study Locations (1)
Washington
- University of Washington - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2018-04-29 |
| Est. Completion | 2019-04-29 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03509675
The ClinicalTrials.gov registry entry for NCT03509675 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 18-participant average among 3 other Oral Lichen Planus trials with a reported enrollment target (28% higher). The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Oral Lichen Planus appearing as the primary indexed condition, and to 2 interventions - of which Placebos is the first listed.
NCT03509675 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.
Frequently Asked Questions
What is clinical trial NCT03509675 about?
NCT03509675 is a clinical study titled "Use of Topical NSAID to Reduce Pain in Oral Lichen Planus and Oral Lichenoid Lesions.". Oral lichen planus (OLP) is a common chronic autoimmune disease associated with cell-mediated immunological dysfunction. Symptomatic OLP is painful and complete healing is rare. Current treatments for lichen planus and lichenoid mucositis are usually directed towards reducing the symptoms. This dou...
What is the current status of trial NCT03509675?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2018-04-29. Estimated completion is 2019-04-29.
What conditions does trial NCT03509675 study?
This clinical trial studies the following conditions: Oral Lichen Planus, Oral Lichenoid Mucositis, Oral Lichenoid Reaction.
What interventions are being tested in trial NCT03509675?
The interventions under investigation include: Placebos (DRUG), Ibuprofen suspension 5mg/100ml (DRUG).
Who is sponsoring clinical trial NCT03509675?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03509675 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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