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

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

Kakei Yasumasa

Kobe University Hospital

7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo

ykakei@med.kobe-u.ac.jp

Kitahiro Yumi

Kobe University Hospital

7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo

+81-78-382-6659

ykitahi@med.kobe-u.ac.jp

Recruiting

April. 22, 2022

Interventional

randomized controlled trial

double blind

placebo control

crossover assignment

supportive care

(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.

(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.

Both

oral lichen planus

Ibuprofen gargle / placebo gargle

gargle, mouse wash, rinse, mouth bath

D017676

D046650

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

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

+81-78-382-6669

Mar. 22, 2022

none