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MucoLock™ for Stomatitis (Mouth Pain)

This study is testing a product called MucoLock™ Oral Gel to see how well it can treat stomatitis (mouth pain or burning sensation) and if it's safe to use. MucoLock™ is thought to work by affecting certain proteins in the body (KINASE INHIBITOR, TYROSINE KINASE). You might be able to join if you are 18 or older and have significant mouth pain or burning. Participants will use MucoLock™ as a "swish and spit" solution three times a day for 28 days. The main goal is to see how much your pain changes after 28 days. The current recruitment status is unclear, and the study plans to enroll 25 people.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 25 participants.
What's involved
You would use MucoLock™ Oral Gel as an oral rinse for 5 minutes, three times a day, for 28 days.
Compensation
Not stated in the trial record.
Follow-up
Your pain will be measured at 28 days to see the treatment's effect.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07506018

MucoLock™ for Treatment of Stomatitis

Recruiting
NAAges 18+InterventionalTreatment
Baptist Health South Florida
~25 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:MucoLock Oral Gel

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Visual Analog Scale (VAS) pain score
Measured over 28 days

Conditions

Stomatitis
Pain
Burning Mouth
Burning Mouth Syndrome
Oral Dysesthesia

Explore related trials

Burning Mouth SyndromeStomatitis

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Alessandro Villa, DDS, PhD, MPH · PRINCIPAL_INVESTIGATOR · Miami Cancer Institute at Baptist Health, Inc.

Who to contact

Alessandro Villa, DDS, PhD, MPH
[email protected]
(786) 596-2000
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change in Visual Analog Scale (VAS) pain score28 days

    Pain will be assessed using the VAS with a score of 0 being no pain and 10 being worst possible pain. Pre- to post-treatment change in VAS pain score will be compared.