Use of Topical NSAID to Reduce Pain in Oral Lichen Planus and Oral Lichenoid Lesions.
Status:
Completed
Trial end date:
2019-04-29
Target enrollment:
Participant gender:
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.