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MucoLock™ for Treatment of Stomatitis
A Phase II Open-Label Trial of MucoLock™ Oral Rinse for the Treatment of Stomatitis Characterized by Oral Dysesthesia
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- MucoLock Oral Gel (device)
Sponsor: Baptist Health South Florida · Participants: 25 · Started: Jul 16, 2026
Contact the study team
- Alessandro Villa, DDS, PhD, MPH · Phone: (786) 596-2000
- Wilfred W Hendron, II · Phone: (786) 596-2000
Official record on ClinicalTrials.gov — NCT07506018
Locations in the U.S.
| Florida | Miami Cancer Institute at Baptist Health, Inc., Miami |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.