25 Participants NeededMy employer runs this trial

MucoLock for Mouth Sores

AV
WW
Overseen ByWilfred W Hendron, II
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called MucoLock™ to determine its effectiveness in reducing pain and burning sensations in the mouth. Participants will use it like a mouthwash, swishing and then spitting it out, three times daily for 28 days. The trial seeks individuals experiencing significant mouth pain or burning sensations. Those who frequently endure mouth discomfort affecting daily activities might find this trial suitable. As an unphased trial, it provides a unique opportunity to contribute to groundbreaking research that could enhance daily life for those with mouth discomfort.

Do I need to stop taking my current medications for the trial?

Yes, if you are using topical therapy for mouth pain or any opioid pain medication, you will need to stop these for 2 weeks before starting the trial. If you are on another investigational drug, you should also stop it 2 weeks prior to the study.

What prior data suggests that MucoLock™ is safe for treating mouth pain or burning sensation?

Research has shown that MucoLock™ has undergone safety testing for treating mouth pain or burning sensations. Previous studies have examined its tolerability. Although specific details from these studies aren't provided, its inclusion in a trial suggests initial confidence in its safety.

MucoLock™ is used like a mouthwash, a generally safe method. So far, available research has not reported any major serious side effects from MucoLock™. If MucoLock™ were unsafe, it likely wouldn't be in this trial. Always consult a healthcare provider to understand any potential risks before participating.12345

Why are researchers excited about this trial?

MucoLock™ is unique because it offers a new method for managing mouth sores with its easy-to-use "swish and spit" oral gel. Unlike standard treatments, which often involve topical creams or systemic medications, MucoLock™ provides a straightforward application that targets sores directly in the mouth. This delivery method not only simplifies the treatment process but also minimizes the risk of systemic side effects, which is a significant advantage over traditional options. Researchers are excited about MucoLock™ because it could offer a more convenient and potentially more effective way to provide relief for individuals suffering from painful mouth sores.

What evidence suggests that MucoLock™ might be an effective treatment for mouth pain?

Research shows that treatments like MucoLock™ can help reduce mouth pain or burning. Studies have found that similar treatments can greatly lessen the severity and frequency of mouth sores. For example, about half of the patients in some studies experienced symptom improvement within two weeks. MucoLock™ adheres well to the inside of the mouth, ensuring the medicine remains where needed. This method is considered more effective than treatments that do not stay in place as well. Overall, early research suggests that MucoLock™ could help manage mouth soreness by providing targeted and lasting relief.12678

Who Is on the Research Team?

AV

Alessandro Villa, DDS, PhD, MPH

Principal Investigator

Miami Cancer Institute at Baptist Health, Inc.

Are You a Good Fit for This Trial?

This trial is for adults (18+) with severe mouth pain or burning sensations lasting at least a week. People can't join if they have certain neurological issues, alcohol use disorder, advanced kidney disease, oral cancer under treatment, are using opioids or other topical mouth pain treatments, or can't follow study instructions.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent document
I am 18 years old or older.
I have had severe mouth pain or burning (score 7 or higher) in the past week.

Exclusion Criteria

I have problems with coordination or balance (ataxia).
Known alcohol use disorder
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
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use MucoLock™ topical solution as a 'swish and spit' solution three times per day for 5 minutes each time, for 28 days

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • MucoLock™

Trial Overview

The study tests MucoLock Oral Gel as a swish-and-spit solution used three times daily for 28 days to see how well it relieves mouth pain and burning sensations in people with these symptoms.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: MucoLock™ Topical SolutionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Baptist Health South Florida

Lead Sponsor

Trials
54
Recruited
8,100+

Professional Compounding Centers of America

Industry Sponsor

Trials
1
Recruited
50+

Citations

NCT07506018 | MucoLock™ for Treatment of Stomatitis

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 ...

Efficacy and Safety of Topical Steroid Therapy for Oral ... - PMC

Among the six included studies, several reported statistically significant reductions in OM incidence and severity, with no cases of oral ...

Topical Treatment of Oral Mucositis in Cancer Patients - PMC

Of the included studies, 50% presented a resolution of OM within 14 days. Topical natural agents yielded good results with average resolution time of 3–7 days.

Dexamethasone solution and dexamethasone in Mucolox ...

Although effective in most cases, topical corticosteroids are challenging to apply due to their poor adherence to oral mucosal surfaces, because ...

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Mouth rinsing with various agents has demonstrated effectiveness in the prevention and treatment of radiation-induced mucositis (OM), but evidence for the same ...

MucoLox Formulation to Mitigate Mucositis Symptoms in ...

The safety objective is to summarize the rates of potential side effects related to each oral formulation. A total of 60 eligible subjects will be enrolled and ...

Multimodal Analgesic Strategies for Cancer-Related Oral ...

This Fast Fact assimilates the published evidence to offer multimodal analgesic strategies for oral mucositis pain from cancer treatment.

Therapeutic Agents for Oral Mucosal Disease Treatment ...

These medications are all contraindicated in microbial diseases. If given to patients with microbial diseases, microbial proliferation is ...