The treatment of mucosal ulcers and stomatitis varies in duration depending on the severity and treatment strategy. Drugs are today given as cream, ointment’s or mouth wash, where drug is applied for a certain time ranging from 15 min to a couple of hours. In between treatment patients are left with no support. A Rivelin Plain patch would work as a mechanical barrier protecting the diseased area from mechanical disruption. This protection may in itself have a healing effect.
Pilot Study in healthy volunteers
The Rivelin® plain patch was applied to 26 healthy volunteers at the gingiva, tongue and cheek. The min. targeted adhesion time of 15 minutes was met and extensively exceeded for all application sites. An acceptability questionnaire revealed a predominant positive feedback.
Phase Ib study in patients with oral lichen planus (OLP)
The tolerability and compliance of Rivelin® plain patches applied to OLP patients (n=30) with ulcerative and/or erythematous symptomatic lesions will be address in a clinical study. The study will commence Q2 2017 and be executed in Munich, Bonn and Düsseldorf, Germany.