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New treatment option for Stomatitis
Official title MucoLock™ for Treatment of Stomatitis
ClinicalTrials.gov ID: NCT07506018
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.