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: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Treatments: Anti-Inflammatory Agents; Ibuprofen

Criteria

Inclusion Criteria:

• Speak English

• Have a symptomatic form of the disease.

• Are at least 18 years of age.

Exclusion Criteria:

• 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