oral lichen planus
Conditions
Interventions
Sponsors
Kakei Yasumasa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of adverse event. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactYumi Kitahiro
Kobe University Hospital
Outcome results
None listed