MucoLock™ to relieve mouth pain from stomatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.