| NCT ID | NCT07506018 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Baptist Health South Florida |
| Condition | Stomatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2026-04-15 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2026-04-15 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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.
Contact & Investigator
Alessandro Villa, DDS, PhD, MPH
PRINCIPAL INVESTIGATOR
Miami Cancer Institute at Baptist Health, Inc.
Frequently Asked Questions
Who can join the NCT07506018 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stomatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07506018 currently recruiting?
Yes, NCT07506018 is actively recruiting participants. Contact the research team at Alessandro.Villa@baptisthealth.net for enrollment information.
Where is the NCT07506018 trial being conducted?
This trial is being conducted at Miami, United States.
Who is sponsoring the NCT07506018 clinical trial?
NCT07506018 is sponsored by Baptist Health South Florida. The principal investigator is Alessandro Villa, DDS, PhD, MPH at Miami Cancer Institute at Baptist Health, Inc.. The trial plans to enroll 25 participants.