CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 23 enrolled
Drug / intervention
Ibuprofen suspension 5mg/100ml +1 moredrug
Likely dose
Ibuprofen suspension 5mg/100mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03509675
NCT03509675Phase 3Completed

Use of Topical Non-Steroidal Anti- Inflammatory to Reduce Pain in Oral Lichen Planus and Oral Lichenoid Lesions.

University of Washington·interventional·Posted Apr 26, 2018·Updated May 8, 2020

In Brief

A Phase 3 clinical trial evaluating Ibuprofen suspension 5mg/100ml and Placebos for Oral Lichen Planus and 2 related conditions. Completed, enrolled 23 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedApr 26, 2018
Enrollment StartApr 29, 2018
Primary CompletionJan 30, 2019
Study CompletionApr 29, 2019
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 8.2 years ago

Interventions

Ibuprofen suspension 5mg/100mldrug

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

Placebosdrug

Placebo