Actively Recruiting
MucoLock™ for Treatment of Stomatitis
Led by Baptist Health South Florida · Updated on 2026-04-20
25
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
Sponsors
B
Baptist Health South Florida
Lead Sponsor
P
Professional Compounding Centers of America
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
MucoLock™ for Treatment of Stomatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years and older
- Individuals with oral dysesthesia having a worst Visual Analog Scale sensitivity or burning score of 7 or higher over the last week
- Ability to understand and willingness to sign a written informed consent document
You will not qualify if you...
- Inability to comply with study instructions
- Uncontrolled intercurrent illness or psychiatric/social conditions limiting compliance
- Any condition or abnormality that may compromise participant safety or data quality as judged by the Investigator
- Advanced kidney disease
- Receiving antineoplastic therapy (e.g., tyrosine kinase inhibitors, radiation) that increases oral dysesthesia risk
- Known altered mental status, encephalopathy, or cognitive impairment
- Ataxia
- Known alcohol use disorder
- Current opioid therapy
- Diagnosis of oral cancer undergoing therapy
- Currently using topical therapy for mouth pain (e.g., lidocaine, Magic mouthwash)
- Use of any opioid pain medication
- Treatment with another investigational drug or intervention within 2 weeks prior to study start (washout period required)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, United States, 33176
Actively Recruiting
Research Team
A
Alessandro Villa, DDS, PhD, MPH
CONTACT
W
Wilfred W Hendron, II
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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