NCT07506018NARecruiting
MucoLock™ for Treatment of Stomatitis
Baptist Health South Florida
Start Date
7/16/2026
Completion Date
8/1/2028
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 Criteria
Age Range: 18 years to No maximum
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.
Interventions
DEVICE
MucoLock Oral Gel
Conditions
StomatitisPainBurning MouthBurning Mouth SyndromeOral Dysesthesia
Locations
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida 33176
United States