Nitric Oxide Releasing Mouthwash (NORM) for the Management of Oropharyngeal Candidiasis

Inclusion criteria

• ✓. At least 19 years old at the time of consent.
• ✓. Participants must be diagnosed with clinical candidiasis.
• ✓. Have no acute illnesses or hospitalizations within 30 days prior to enrollment, no planned procedures during the anticipated study participation, and no newly diagnosed chronic illnesses that are not deemed stable by the participant's primary care physician), in the opinion of the Investigator, based on medical history (i.e., absence of any clinically relevant abnormality) during Screening.
• ✓. Participants must not have been part of any clinical trial for the past 30 days and may not be taking any other investigational therapy related to treatment of candidiasis.
• ✓. If female, be surgically sterile or post-menopausal (no menses for at least 12 months), or if of childbearing potential, must be using an acceptable method of contraception such as a combination estrogen/progestin hormonal contraceptive (oral or injected) for at least 1 month prior to Day -14, or such items as an intrauterine device (IUD), intrauterine system (IUS), transdermal hormonal implant, vaginal hormonal ring, or 2 forms of the following: diaphragm, cervical cap, patch, condom, spermicide, or sponge. Total abstinence is permitted. If local regulations deviate from the previously listed contraception methods to prevent pregnancy, local requirements will apply. In addition, females of childbearing potential must agree to continue to use their method of birth control for the duration of the study.
• ✓. If male, be surgically sterile, or agree to use appropriate contraception (latex condom with spermicide) when engaging in sexual activity and agree to not donate sperm for the duration of the study.
• ✓. Be able to understand and provide written, informed consent.
• ✓. Must be willing and able to manage a treatment regimen and attend assessment study visits.