Oramelts with DGL: Treatment of Minor RAU

DESCRIPTION: Recurrent aphthous ulcers (RAU) are one of the most common inflammatory conditions of the oral mucosa, affecting approximately 20% of the U.S. population. While the etiology is, as yet, poorly understood, treatments include topical anesthetics, steroidal anti-inflammatories, H2 receptor antagonists (Tagamet) for gastric ulcers, and thalidomide. These treatment options are of limited efficacy for reducing the sensitivity associated with the lesions, can be costly, and can result in serious side effects that preclude their use. Orahealth Corporation has developed a semi-adherent, fully dissolving oral patch called Oramelts and has developed a version of Oramelts containing Deglycerinated licorice (DGL) for topical treatment of minor recurrent aphthous ulcers. DGL is a water extract of glycyrrhiza (licorice root) with acids and related salts mostly removed. DGL has been extensively used and clinically tested in the UK for treatment of gastric ulcers with no significant side effects, establishing a very high degree of safety. Only one report in the extant literature has applied DGL to minor RAU (Das et al., 1989). That study found significant relief of pain in 75% of subjects and increased healing rate of lesions. Nevertheless, this study lacked a control group and used DGL in rinse form so that it could only contact the lesion briefly while the subject gargled with the rinse. Oramelts with DGL allow for continued contact of DGL with the affected area. We propose to determine the efficacy of Oramelts with DGL by conducting a double-blind, randomized controlled clinical trial comparing Oramelts with DGL and Oramelts without active ingredients in 36 to 60 participants with minor RAU. We will verify or correct the following claims: For ordinary canker sores (minor recurrent aphthous ulcers), Oramelts with DGL will: - reduce canker sore sensitivity within 20 minutes, and - achieve healing within two or three days when used as directed. If these claims are verified in clinical trials, Orahealth Corporation will take the product to market, providing health benefits to the 20% of people who suffer from minor recurrent aphthous ulcers.