Devintec OR-AT0222 Oral Gel for the Treatment of Canker Sores: A Double Blind, Randomized, Placebo Controlled Clinical Investigation

Each subject will be asked to sign the Informed Consent Form (ICF). A total of 46 subjects will be enrolled, 23 for each group will be randomized with a 1:1 ratio and allocated to one treatment group (blinded assignment). Group 1: Treatment with OR-AT0222 and Group 2: Treatment with Placebo. The patients will be asked to apply 1-2 drops of the gel on their ulcers three times a day for 7 days and to record the aphthous pain level based on visual analogue scale (VAS) using a number scale from 0 to 10, with 0 no pain at all and 10 the most severe pain. The patients have to refrain from eating and drinking for at least 30 minutes after gel application. The study will also assess tolerability and safety (adverse events). At day 8, the patients will be examined again. Complete healing (the time when the pseudomembrane and the erythematous border disappear) will be confirmed by clinician examination at the end of the treatment period. Reduction of the number of ulcers respect to baseline and percent of lesions with complete healing will be also assessed