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

Phase 2

Recruiting

• Conditions: oral lichen planus; D017676

• Registration Number: JPRN-jRCTs051220010
• Lead Sponsor: Kakei Yasumasa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 24

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

(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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified