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

NCT03509675 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: STUDY00003936
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Oral Ulceration

Outcome Measures

Primary Outcomes (1)

• Self-reported Pain Scores Using 100m Visual Analog Scale 0-100 Pain Score.

  We will be looking for an improvement in symptoms through summation of the reduction in pain using a 100mm, where 0= no pain and 100= worst pain experienced Visual Analog Scale(VAS). Minimum pain level of 30mm out of 100 mm was an inclusion criteria in the study. Participants were asked to record spontaneous pain level at day 0, day 4 and at the end of day 7 timepoints for both arms/groups. Lower scores mean a better outcome.

  Total pain improvement over day 0 to day 7 (summation of improvement over 7 days)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo suspension was compounded with the same taste as the active medication but without the active ingredient.

Drug: Placebos

Active ingredient

ACTIVE COMPARATOR

The topical suspension of the topical NSAID was 100 mg per 5 ml concentration of ibuprofen, with similar ingredients as OTC children's ibuprofen and was compounded by an external drug service.

Drug: Ibuprofen suspension 5mg/100ml

Interventions

Ibuprofen suspension 5mg/100ml DRUG

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

Also known as: Children's Motrin

Active ingredient

Placebos DRUG

Placebo

Also known as: Oral suspension without active ingredient

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Lichen Planus, Oral; Oral Ulcer

Interventions

Suspensions

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Limitations and Caveats

Inadequate sample size may have prevented us from observing a significant pain reduction.

Results Point of Contact

• Title: Stuart Taylor
• Organization: University of Washington

stuartt@uw.edu

206-221-3772

Study Officials

• Stuart Taylor, DMD, MSD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blinded crossover study
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor: Oral Medicine

Model Details: Non Steroidal anti-inflammatory topical rinse

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: April 26, 2018
• Study Start: April 29, 2018
• Primary Completion: January 30, 2019
• Study Completion: April 29, 2019
• Last Updated: May 8, 2020
• Results First Posted: May 8, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)