Overview
The purpose of this research is to test how well people can tolerate MucoLock™ as a treatment for mouth pain or burning sensation and how well it works to reduce mouth pain or burning sensation. Study participants will be asked to use MucoLock™ topical solution as a "swish and spit" solution (similar to mouthwash) three times per day for 5 minutes each time, for 28 days.
Eligibility
Inclusion Criteria:
- Age 18 years and older
- Individuals with oral dysesthesia (worst VAS sensitivity/burning score ≥ 7 over the last week)
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Inability to comply with study instructions
- Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements\
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the participant or the quality of the data.
- Advanced kidney disease
- Patients receiving antineoplastic therapy \[e.g., tyrosine kinase inhibitors (TKIs), radiation\] that could increase the risk of oral dysesthesia
- Known altered mental status, encephalopathy, or cognition impairment
- Ataxia
- Known alcohol use disorder
- Concomitant opioid therapy
- Diagnosis of oral cancer currently undergoing therapy
- Already using topical therapy for mouth pain (e.g., lidocaine, Magic mouthwash)\
- Any opioid pain medication\*
- Treatment with another investigational drug or other intervention within 2 weeks. Patients will be recommended to stop previous medication for 2 weeks before starting the study treatment.
(asterisk) \*Modifiable criteria, with a timeframe of 2 weeks for a washout period.
