[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"oral-pain\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:oral-pain":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100639225","observational-study-of-orosedal-in-sore-throat-and-minor-oral-lesions-100639225",false,"NCT07620353","Observational Study of OROSEDAL in Sore Throat and Minor Oral Lesions","Relief of Sore Throat Pain or Minor Mouth Lesions, Including Minor Aphthous Ulcers, in Children and Adults Treated With OROSEDAL: An Observational Study","Inclusion Criteria:\n\n* Age 8 years or older, including adults.\n* Sore throat or minor mouth lesion, including minor aphthous ulcer or histologically confirmed oral lichen planus, evolving for less than 15 days.\n* Global pain intensity over the previous 24 hours, spontaneous and\u002For during chewing or swallowing, \\>40 mm on a 0-100 mm visual analog scale.\n* OROSEDAL prescription decided by the investigator before inclusion.\n* Written informed consent from the patient or from one parent for minors.\n\nExclusion Criteria:\n\n* More than 3 visible oral mucosal lesions.\n* Post-intubation sore throat.\n* Corticosteroid use ongoing or within 3 days before inclusion.\n* NSAID use ongoing or within 3 days before inclusion.\n* Local treatment on the lesion ongoing or within 3 days before inclusion.\n* Non-opioid analgesics, including paracetamol, ongoing or within 3 days before inclusion, unless continued for at least 24 hours at the same daily dose as during the 24 hours before inclusion.\n* Weak or strong opioid analgesics ongoing or within 3 days before inclusion.\n* Signs suggesting a condition requiring additional investigations according to the investigator, except rapid streptococcal throat testing.\n* Signs suggesting a condition requiring corticosteroid prescription according to the investigator.\n* Systemic disease, such as rheumatoid arthritis, lupus, or Behçet disease.\n* Any contraindication listed in OROSEDAL instructions for use.\n* Known allergy to any OROSEDAL component, including glycerol, tamarind extract, mallow extract, benzyl alcohol, orange blossom flavoring, or xylitol.\n* Non-compliance with precautions for use listed in the instructions for use.","ALL","8 Years",{"count":19,"type":20},124,"ESTIMATED","OBSERVATIONAL","This prospective, multicenter, national, observational, non-interventional post-market clinical follow-up study will evaluate the performance and safety of OROSEDAL in children and adults with sore throat or minor oral lesions, including minor aphthous ulcers and histologically confirmed oral lichen planus. OROSEDAL is prescribed in routine practice before inclusion. Patients will be followed for 6 ± 1 days and will complete self-assessments of pain, swallowing discomfort, treatment use, and adverse events.",[24,25,26,27,28],"Sore Throat","Aphthous Ulcer","Oral Lichen Planus","Minor Mouth Lesion","Oral Pain",[30,31,32,33,34,35,36],"sore throat","aphthous ulcer","mouth ulcer","oral lesion","PMCF","real-world evidence","swallowing discomfort","RECRUITING","2026-05-27",{"date":40,"type":41},"2026-06-02","ACTUAL",{"date":43,"type":41},"2026-03-05",{"date":45,"type":20},"2027-07",{"name":47,"class":48},"Laboratoires Elerte","INDUSTRY",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":49},"100600678","phase-2-mucoadhesive-modified-release-formulations-for-the-topical-treatment-of-symptomatic-oral-lichen-planus-100600678","NCT07100613","Mucoadhesive Modified-Release Formulations for the Topical Treatment of Symptomatic Oral Lichen Planus","Efficacy of a Microparticulate Muco-adhesive Patch Containing Drug-nutraceutical Association in paTIents Affected by Oral Mucosa Alterations (EMPATIA)","EMPATIA","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Clinical suspicion of Oral Lichen Planus (OLP).\n* Histological confirmation of OLP based on World Health Organization (WHO) criteria (presence of hyperkeratosis, acanthosis, basal cell degeneration, and a band-like lymphocytic infiltrate in the lamina propria).\n* Absence of epithelial dysplasia.\n* Ability to understand and sign informed consent.\n\nExclusion Criteria:\n\n* Previous diagnosis or treatment for OLP.\n* Use of topical or systemic corticosteroids in the last 4 weeks.\n* Use of medications known to cause lichenoid reactions.\n* History of allergic reactions to dental materials (e.g., amalgam).\n* Hematological disorders or immunodeficiencies.\n* Pregnancy or breastfeeding.\n* Current use of immunosuppressive therapies.\n* Inability or unwillingness to comply with study procedures.","18 Years",{"count":60,"type":20},45,"INTERVENTIONAL",[63],"PHASE2","The goal of this clinical trial is to learn if a mucoadhesive patch containing clobetasol alone or in combination with resveratrol can reduce symptoms and improve quality of life in adults with Oral Lichen Planus (OLP). The main questions it aims to answer are:\n\nDoes the patch reduce oral pain and burning sensations? Does it improve the appearance of oral lesions and patients' daily well-being?\n\nResearchers will compare:\n\nA patch containing clobetasol A patch containing clobetasol and resveratrol A standard clobetasol 0.05% ointment in an adhesive base\n\nParticipants will:\n\nApply their assigned treatment to the oral lesion daily for 30 days Attend three clinical visits for evaluations and imaging Complete questionnaires about pain, symptoms, and treatment experience",[26,66,67,28],"Oral Lichen Planus Related Stress","Oral Mucosal Disease",[69,70,71,72,73,74,75],"mucoadhesive patch","oral lichen planus","clobetasol","resveratrol","drug delivery system","Optical coherence tomography","Ora pain","2025-07-30",{"date":78,"type":41},"2025-08-03",{"date":80,"type":41},"2024-09-04",{"date":82,"type":20},"2027-10-01",{"name":84,"class":85},"University of Palermo","OTHER"]