MucoLock™ to relieve mouth pain from stomatitis
A Phase II Open-Label Trial of MucoLock™ Oral Rinse for the Treatment of Stomatitis Characterized by Oral Dysesthesia
This study will test whether using MucoLock™ as a swish-and-spit mouth rinse three times a day for 28 days can reduce burning and pain in adults with oral dysesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Baptist Health South Florida Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT07506018 on ClinicalTrials.gov |
What this trial studies
Participants who are 18 or older with significant oral dysesthesia (worst VAS sensitivity/burning score ≥ 7 over the last week) will use MucoLock™ topical solution as a swish-and-spit rinse for five minutes, three times daily, for 28 days. The trial is interventional and conducted at a single center, with safety and tolerability monitored along with changes in mouth pain and burning. Exclusion criteria remove patients with uncontrolled medical or psychiatric issues, advanced kidney disease, ongoing antineoplastic therapy, opioid use, alcohol use disorder, or current topical mouth-pain treatments. Outcomes will focus on symptom change and participant tolerability of the product.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with oral dysesthesia or severe mouth burning (worst VAS ≥ 7 in the past week) who can follow study procedures and provide informed consent.
Not a fit: People currently undergoing cancer therapy, those on opioids, with advanced kidney disease, uncontrolled psychiatric illness, alcohol use disorder, or already using topical mouth treatments are unlikely to benefit or be eligible for this protocol.
Why it matters
Potential benefit: If successful, MucoLock™ could reduce oral burning and pain and help improve eating and daily comfort for people with stomatitis.
How similar studies have performed: There is limited published data on MucoLock™ specifically, and similar topical barrier or coating rinses have produced mixed or modest results in small studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Miami, Florida
- Miami Cancer Institute at Baptist Health, Inc. — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Alessandro Villa, DDS, PhD, MPH — Miami Cancer Institute at Baptist Health, Inc.
- Study coordinator: Alessandro Villa, DDS, PhD, MPH
- Email: Alessandro.Villa@baptisthealth.net
- Phone: (786) 596-2000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.