[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631848":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":34,"responsibleParty":51,"collaborators":53,"id":57,"slug":20,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":20,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":20,"enrollmentInfo":65,"targetDuration":20,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":20,"overallStatus":36,"whyStopped":20,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Baptist Health South Florida","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"MucoLock™ Topical Solution","EXPERIMENTAL","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.",[13],"Device: MucoLock Oral Gel",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","MucoLock Oral Gel","15 mL, oral rinse for 5 minutes and spit (do not swallow), 3 times per day, for 28 days",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Alessandro Villa, DDS, PhD, MPH","Miami Cancer Institute at Baptist Health, Inc.","PRINCIPAL_INVESTIGATOR",[27,31],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","(786) 596-2000","Alessandro.Villa@baptisthealth.net",{"name":32,"role":28,"phone":29,"phoneExt":20,"email":33},"Wilfred W Hendron, II","Wilfred.Hendronii@baptisthealth.net",[35],{"facility":24,"status":36,"city":37,"state":38,"zip":39,"country":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Miami","Florida","33176","United States",{"type":42,"coordinates":43},"Point",[44,45],-80.19366,25.77427,{"lat":45,"lon":44},[48,49,50],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},{"name":32,"role":28,"phone":29,"phoneExt":20,"email":33},{"name":23,"role":25,"phone":20,"phoneExt":20,"email":20},{"type":52,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[54],{"name":55,"class":56},"Professional Compounding Centers of America","INDUSTRY","100631848",false,"NCT07506018","MucoLock™ for Treatment of Stomatitis","A Phase II Open-Label Trial of MucoLock™ Oral Rinse for the Treatment of Stomatitis Characterized by Oral Dysesthesia","Inclusion Criteria:\n\n* Age 18 years and older\n* Individuals with oral dysesthesia (worst VAS sensitivity\u002Fburning score ≥ 7 over the last week)\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Inability to comply with study instructions\n* Uncontrolled intercurrent illness or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\\*\n* 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.\n* Advanced kidney disease\n* Patients receiving antineoplastic therapy \\[e.g., tyrosine kinase inhibitors (TKIs), radiation\\] that could increase the risk of oral dysesthesia\n* Known altered mental status, encephalopathy, or cognition impairment\n* Ataxia\n* Known alcohol use disorder\n* Concomitant opioid therapy\n* Diagnosis of oral cancer currently undergoing therapy\n* Already using topical therapy for mouth pain (e.g., lidocaine, Magic mouthwash)\\*\n* Any opioid pain medication\\*\n* 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.\n\n(asterisk) \\*Modifiable criteria, with a timeframe of 2 weeks for a washout period.","ALL","18 Years",{"count":66,"type":67},25,"ESTIMATED","INTERVENTIONAL",[70],"NA","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.",[73,74,75,76,77],"Stomatitis","Pain","Burning Mouth","Burning Mouth Syndrome","Oral Dysesthesia","2026-04-16",{"date":80,"type":81},"2026-04-20","ACTUAL",{"date":83,"type":81},"2026-04-15",{"date":85,"type":67},"2028-05",{"name":5,"class":6},1]