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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

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

ArmDescriptionAssigned 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.
  • Device: MucoLock Oral Gel
    15 mL, oral rinse for 5 minutes and spit (do not swallow), 3 times per day, for 28 days

Recruiting Locations

Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida 33176
Contact:
Alessandro Villa, DDS, PhD, MPH
(786) 596-2000
Alessandro.Villa@baptisthealth.net

More Details

Status
Recruiting
Sponsor
Baptist Health South Florida

Study Contact

Alessandro Villa, DDS, PhD, MPH
(786) 596-2000
Alessandro.Villa@baptisthealth.net

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.