Efficacy of Ibuprofen gargle for oral lichen planus: A comparison study.

Efficacy of Ibuprofen gargle for oral lichen planus: a phase II, placebo-controlled, double-blind, randomized, crossover trial.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs051220009

Enrollment

Registered

2022-04-22

Start date

2022-06-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

oral lichen planus

Interventions

Ibuprofen gargle / placebo gargle

D046650

gargle, mouse wash, rinse, mouth bath

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients with oral lichen planus or oral lichen planus-like lesions. (2) Patients with pain in the oral cavity averaging 20 mm or more on the Visual Analog Scale (VAS) over the past 7 days from the date of registration. (3) Patients who are receiving treatment (both systemic and local) for the lesion and have been using the drug at a certain dose for at least 28 days prior to the date of registration. (4) Patients aged 20 years or older at the time of a cquisition consent. (5) Patients for whom documented consent has been obtained regarding their voluntary participation in this clinical study.

Exclusion criteria

Exclusion criteria: (1) Patients who have peptic ulcer. (2) Patients with concurrent severe or uncontrolled concomitant medical conditions. (3) Patients with history of hypersensitivity to any component of ibuprofen gargle. (4) Patients who impaired cardiac function or clinically significant heart disease. (5) Patients with aspirin-induced asthma. (6) Patients who use analgesic drug at least once a week for any chronic pain. (7) Patients with dementia, psychiatric symptoms, drug addiction and alcoholism. (8) Pregnant or lactating women. (9) Patients that the investigator deems inappropriate.

Design outcomes

Primary

Measure	Time frame
Change in VAS before and after 5 minutes of use of the first ibuprofen or placebo gargle on days 1 and 2	—

Secondary

Measure	Time frame
1. Delta VAS before and 15 minutes after the first use of ibuprofen or placebo gargle on days 1 and 2. 2. Delta VAS before and after 5 and 15 minutes of use of the first ibuprofen gargle on days 3 through 5. 3. Time to onset of effect of study drug 4. Duration of effect of study drug 5. Change in Patient Reported Oral Mucositis Symptom scale (PROMS scale) 6. Overall daily efficacy on days 1 to 5. 7. Number of uses (gargle, analgesic drug) per day on days 1 to 5. 8. Adverse Event	—

Measure

Time frame

1. Delta VAS before and 15 minutes after the first use of ibuprofen or placebo gargle on days 1 and 2. 2. Delta VAS before and after 5 and 15 minutes of use of the first ibuprofen gargle on days 3 through 5. 3. Time to onset of effect of study drug 4. Duration of effect of study drug 5. Change in Patient Reported Oral Mucositis Symptom scale (PROMS scale) 6. Overall daily efficacy on days 1 to 5. 7. Number of uses (gargle, analgesic drug) per day on days 1 to 5. 8. Adverse Event

—

Contacts

Public ContactYumi Kitahiro

Kobe University Hospital

ykitahi@med.kobe-u.ac.jp+81-78-382-6659

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026