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Recruiting NCT07506018

MucoLock™ for Treatment of Stomatitis

No phase Interventional Stomatitis Pain Burning Mouth Burning Mouth Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MucoLock Oral Gel.
Who it may be relevant to
Registry conditions: Stomatitis, Pain, Burning Mouth, Burning Mouth Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase II Open-Label Trial of MucoLock™ Oral Rinse for the Treatment of Stomatitis Characterized by Oral Dysesthesia

Overview

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.

Interventions

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

Primary outcome measures

  • Change in Visual Analog Scale (VAS) pain score [Time frame: 28 days]
Secondary outcome measures (3)
  • Change in Oral Health Impact Profile-14 (OHIP-14) total score [Time frame: 28 days]
  • Change in Oral Health Impact Profile-14 (OHIP-14) score (dichotomized) [Time frame: 28 days]
  • Incidence of adverse events by severity and relatedness [Time frame: 28 days]

Eligibility criteria

Inclusion 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

Exclusion criteria

  • 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 criteria, with a timeframe of 2 weeks for a washout period.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Miami Cancer Institute at Baptist Health, Inc. — Miami

Publications

  • Patton LL, Siegel MA, Benoliel R, De Laat A. Management of burning mouth syndrome: systematic review and management recommendations. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Mar;103 Suppl:S39.e1-13. doi: 10.1016/j.tripleo.2006.11.009. PMID 17379153
  • Sun A, Wu KM, Wang YP, Lin HP, Chen HM, Chiang CP. Burning mouth syndrome: a review and update. J Oral Pathol Med. 2013 Oct;42(9):649-55. doi: 10.1111/jop.12101. Epub 2013 Jun 16. PMID 23772971
  • US Food & Drug Administration. MucoLock Oral Gel. 510(K) Premarket Notification. 2021; https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203091

Identifiers

NCT: NCT07506018 · 2025-VIL-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗