A Phase II Open-Label Trial of MucoLock™ Oral Rinse for the Treatment of Stomatitis Characterized by Oral Dysesthesia
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Florida
Miami Cancer Institute at Baptist Health, Inc.
RECRUITING
Miami
Contact Information
Primary
Alessandro Villa, DDS, PhD, MPH
Alessandro.Villa@baptisthealth.net
(786) 596-2000
Backup
Wilfred W Hendron, II
Wilfred.Hendronii@baptisthealth.net
(786) 596-2000
Time Frame
Start Date: 2026-04-15
Estimated Completion Date: 2028-05
Participants
Target number of participants: 25
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Professional Compounding Centers of America
Leads: Baptist Health South Florida