MucoLock™ for Treatment of Stomatitis
A Phase II Open-Label Trial of MucoLock™ Oral Rinse for the Treatment of Stomatitis Characterized by Oral Dysesthesia
Baptist Health South Florida
25 participants
Apr 15, 2026
INTERVENTIONAL
Conditions
Summary
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 Criteria3
- 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 Criteria14
- 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.
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Interventions
15 mL, oral rinse for 5 minutes and spit (do not swallow), 3 times per day, for 28 days
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07506018