MucoLock™ for Treatment of Stomatitis
Purpose
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.
Conditions
- Stomatitis
- Pain
- Burning Mouth
- Burning Mouth Syndrome
- Oral Dysesthesia
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental MucoLock™ Topical Solution |
MucoLock™ oral gel will be used as a "swish and spit" (similar to using mouthwash), 15 mL three times per day, for 5 minutes each time, for 28 days. |
|
Recruiting Locations
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida 33176
Miami, Florida 33176
More Details
- Status
- Recruiting
- Sponsor
- Baptist Health South Florida