Aphthous Ulcer, Minor Mouth Lesion, Oral Lichen Planus, Oral Pain, Sore Throat
Conditions
Keywords
sore throat, aphthous ulcer, mouth ulcer, oral lesion, PMCF, real-world evidence, swallowing discomfort
Brief summary
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.
Detailed description
OROSEDAL is a CE-marked medical device intended to relieve sore throat, aphthous ulcers, oral lichen planus, and minor mouth lesions through a mechanical barrier and hydrating effect. The study is conducted in French general practice under real-life conditions of use. The decision to prescribe OROSEDAL is made independently from study participation. Eligible patients aged 8 years or older with sore throat or minor oral lesions evolving for less than 15 days and baseline global pain intensity \>40 mm on a 0-100 mm visual analog scale will be enrolled. Data will be collected at inclusion, through a daily self-assessment diary, and at Day 6 ± 1 day or early termination. The primary endpoint is the proportion of patients with a reduction \>20 mm in global pain intensity over the previous 24 hours between Day 0 and Day 1 evening. Secondary endpoints assess pain response at Day 6, immediate pain relief after first use, daily pain evolution, swallowing discomfort, global patient-rated effectiveness, associated symptoms, safety/tolerability, device deficiencies, and compliance.
Interventions
DEVICEOROSEDAL
OROSEDAL is an oral spray medical device used according to its instructions for use or according to the physician's prescription. It acts mechanically through barrier-forming and hydrating effects intended to soothe irritation and relieve pain in sore throat, aphthous ulcers, oral lichen planus, and minor mouth lesions.
Sponsors
Laboratoires Elerte
Clin-Experts
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 8 years or older, including adults. * Sore throat or minor mouth lesion, including minor aphthous ulcer or histologically confirmed oral lichen planus, evolving for less than 15 days. * Global pain intensity over the previous 24 hours, spontaneous and/or during chewing or swallowing, \>40 mm on a 0-100 mm visual analog scale. * OROSEDAL prescription decided by the investigator before inclusion. * Written informed consent from the patient or from one parent for minors.
Exclusion criteria
* More than 3 visible oral mucosal lesions. * Post-intubation sore throat. * Corticosteroid use ongoing or within 3 days before inclusion. * NSAID use ongoing or within 3 days before inclusion. * Local treatment on the lesion ongoing or within 3 days before inclusion. * 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. * Weak or strong opioid analgesics ongoing or within 3 days before inclusion. * Signs suggesting a condition requiring additional investigations according to the investigator, except rapid streptococcal throat testing. * Signs suggesting a condition requiring corticosteroid prescription according to the investigator. * Systemic disease, such as rheumatoid arthritis, lupus, or Behçet disease. * Any contraindication listed in OROSEDAL instructions for use. * Known allergy to any OROSEDAL component, including glycerol, tamarind extract, mallow extract, benzyl alcohol, orange blossom flavoring, or xylitol. * Non-compliance with precautions for use listed in the instructions for use.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain responder rate at Day 1 | Day 1 evening | Percentage of patients with a reduction \>20 mm in global pain intensity over the previous 24 hours, measured on a 0-100 mm visual analog scale, between baseline Day 0 and the evening assessment at Day 1. The question asks the patient to rate the global pain over the previous 24 hours related to the sore throat or mouth lesion, with 0 corresponding to no pain and 100 to worst imaginable pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain responder rate at Day 6 or end of study | Day 6 ± 1 day or early termination. | Percentage of patients with a reduction \>20 mm in global pain intensity over the previous 24 hours, measured on a 0-100 mm visual analog scale, between Day 0 and Day 6 ± 1 day or early termination. |
| Immediate change in instantaneous pain intensity after first application | Day 0: before first application, then 5 minutes, 10 minutes, and 60 minutes after first application. | Change in instantaneous pain intensity related to the sore throat or mouth lesion, measured on a 0-100 mm visual analog scale. The patient rates current pain "at the present moment," with 0 corresponding to no pain and 100 to worst imaginable pain. |
| Change in global pain intensity over the study period | Day 0 to Day 6 ± 1 day or early termination. | Evolution of global pain intensity over the previous 24 hours, measured repeatedly on a 0-100 mm visual analog scale at inclusion, in the daily self-assessment diary from Day 1 to the day before Day 6, and at Day 6 ± 1 day or early termination. |
| Change in swallowing discomfort | Day 0 to Day 6 ± 1 day or early termination. | Evolution of swallowing discomfort measured on a 5-point numerical scale from 0 to 4: 0 = no discomfort; 1 = mild discomfort; 2 = moderate discomfort; 3 = severe discomfort; 4 = very severe discomfort. |
| Patient global assessment of effectiveness | Day 6 ± 1 day or early termination. | Patient-rated global effectiveness assessed using a 5-point numerical scale: 0 = not effective at all; 1 = very slightly effective; 2 = slightly effective; 3 = fairly effective; 4 = very effective. |
| Evolution of associated clinical signs | Day 0 to Day 6 ± 1 day or early termination | Change in associated signs reported or observed during the study, including fever, headache, and other associated symptoms. |
| Adverse events, serious adverse events, incidents, and device deficiencies | From inclusion to Day 6 ± 1 day or early termination. | Number and description of adverse events, serious adverse events, incidents, and device deficiencies reported by the patient in the diary or collected by the investigator at visits. Device deficiencies include any malfunction or inadequacy of the medical device when applicable. |
Countries
France
Contacts
CONTACTRenaud Urbinelli
PRINCIPAL_INVESTIGATORDominique DELSART
Outcome results
None listed