A randomized, parallel-group, comparative investigation of M045A in the treatment of recurrent aphthous stomatitis
Recurrent aphthous stomatitis (RAS)
The participants will be invited through an invitation letter and asked to contact the site when they have prodromal symptoms or when they present with ulcers. The participants referred to the study site may also be asked to participate as part of their primary visit if they present with ulcers. All participants will be subjected to an ordinary oral medicine examination including questions about their oral and medical health. After RAS has been established as the diagnosis, the participants will be informed about the clinical investigation by the investigator (oral and written). Informed consent needs to be collected before any investigation-specific activities can take place. Once the consent form has been signed, the PI or delegated site staff will be responsible for the completion of a CRF for each of the 50 research subjects. The CRF will include participant details (initials and subject ID), medical history, visit details and dates, questionnaires, any related adverse events (AEs), any device deficiencies and details of withdrawal from the study if appropriate. Participants will be randomized to active treatment and receive 1-3 patches depending on the number of ulcers. The remaining participants will not be treated (standard care). The patch/patches will be applied by a dentist or dental hygienist. The pain will be estimated by the participants using an NRS, which means that they choose a number between 0 (no pain) and 10 (worst possible pain). The participants will estimate their pain before application and after 10 minutes after application or after non-application of the patch. This pain assessment will be repeated at the Clinic after 1 hour. The pain will then be assessed at different time points (2, 4, 6 and 8 hours) following application/no application of M045A. This data will be collected together with the quality of life data through a diary which the participants will be asked to send in the day after the primary visit. Randomization: Stratificatio
1. Males or females, 12 -70 years of age 2. ≥2 RAS episodes over the past 6 months 3. ≤3 wounds at the time of the study visit 4. The diameter of the wounds <10 mm 5. The pain from RAS ≥4 on the NRS 6. The subjects should have the ability and willingness to provide informed consent
1. Treated at any time with mucosal topical, oral, or systemic corticosteroids less than 1 month prior to screening. 2. On TNF-alpha modulating drugs or DMARDs less than 1 month prior to screening 3. Suffering from any oral mucosal disease other than RAS at the time of enrollment 4. Any other condition as judged by the investigator to make the investigation inappropriate 5. Current alcohol or substance abuse 6. Participating in any other clinical trial or have participated in any other clinical trial within 1 month prior to the study start