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MucoLock™ for Treatment of Stomatitis

NCT07506018 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-04-20

No results posted yet for this study

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.

Conditions

  • Stomatitis
  • Pain
  • Burning Mouth
  • Burning Mouth Syndrome
  • Oral Dysesthesia

Interventions

DEVICE

MucoLock Oral Gel

15 mL, oral rinse for 5 minutes and spit (do not swallow), 3 times per day, for 28 days

Sponsors & Collaborators

  • Professional Compounding Centers of America

    collaborator INDUSTRY

  • Baptist Health South Florida

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-15
Primary Completion
2028-05-31
Completion
2028-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07506018 on ClinicalTrials.gov