Efficacy and safety of Ibuprofen gargle for oral lichen planus: a phase II, open-label, long-term, extension trial.

JRCT ID: jRCTs051220010

Registered date:22/04/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: oral lichen planus
• Date of first enrollment: 23/06/2022
• Target sample size: 24
• Study type: Interventional
• Intervention(s): Ibuprofen gargle

Outcome(s)

• Primary Outcome: Occurrence of adverse event.

Secondary Outcome

Change in Visual Analog Scale (VAS) values before, 5 minutes after, and 15 minutes after the first use of ibuprofen gargle after Day 1.
Changes in the Patient Reported Oral Mucositis Symptom scale (PROMS scale).
Time to onset of effect of study drug.
Duration of effect of study drug.
Overall daily efficacy
Number of times used per day

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients who finished double-blind placebo-controlled phase II clinical trial of Ibuprofen in patients with oral lichen planus (OLP).
(2) Patients who wish to continue to receive ibuprofen-containing products from double-blind placebo-controlled phase II clinical trial
(3) Patients with written informed consent.

Exclude criteria

(1) Patients who have met the termination criteriaover two days for the double-blind placebo-controlled phase II clinical trial.
(2) Patients who have been diagnosed with Dementia, psychiatric symptoms, drug addiction, alcoholism, etc, have been identified by an attending investigator who neither fully comprehends nor cooperates.
(3) Pregnant women or breast-feeding women.
(4) Patients who are not appropriate to participate to the trial.

Related Information

• Primary Sponsor: Kakei Yasumasa