Use of Topical NSAID to Reduce Pain in Oral Lichen Planus and Oral Lichenoid Lesions.

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Oral Lichen Planus, Oral Lichenoid Mucositis, Oral Lichenoid Reaction

In brief

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.

Key facts

Study ID

NCT03509675

Run by

University of Washington

People needed

23

Starts

2018-04-29

Expected to finish

2019-04-29

Last updated by the study team

2020-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Speak English
• Have a symptomatic form of the disease.
• Are at least 18 years of age.

You may not qualify if…

• Known or suspected sensitivity to non-steroidal anti-inflammatory medication
• History of asthma
• History of gastrointestinal ulceration
• History of bleeding disorders
• Use of anti-inflammatory agents in the last 24 hours
• Use of systemic steroid medication in the last 14 days.
• Pregnancy

Where it is running

• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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