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

NCT03509675 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2020-05-08

Study results available
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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

  • Oral Lichen Planus
  • Oral Lichenoid Mucositis
  • Oral Lichenoid Reaction

Interventions

DRUG

Ibuprofen suspension 5mg/100ml

Non-Steroidal Anti-inflammatory Topical Rinse will be used for Symptomatic OLP patients.

DRUG

Placebos

Placebo

Sponsors & Collaborators

Principal Investigators

  • Stuart Taylor, DMD, MSD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-29
Primary Completion
2019-01-30
Completion
2019-04-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03509675 on ClinicalTrials.gov