An observational study in Sore Throat, Aphthous Ulcer and Oral Lichen Planus, sponsored by Laboratoires Elerte. Recruiting at 1 site in France. Open to participants aged 8 Years and older. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by Laboratoires Elerte · 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.
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.
63 studies on the registry are indexed under Stomatitis, Aphthous; 17 are open to participants now.
Browse Stomatitis, Aphthous studies →Laboratoires Elerte is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Compared within Stomatitis, Aphthous, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pharyngitis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Children and adults aged 8 years or older consulting French general practitioners for sore throat or minor oral lesions, including minor aphthous ulcers or histologically confirmed oral lichen planus, for whom OROSEDAL has been prescribed in routine care.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children and adults aged 8 years or older consulting a general practitioner for sore throat or a minor oral lesion, for whom OROSEDAL has been prescribed in routine care before study inclusion.
Device: OROSEDAL
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.
Pain responder rate at Day 1
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.
Time frame: Day 1 evening
Pain responder rate at Day 6 or end of study
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.
Time frame: Day 6 ± 1 day or early termination.
Immediate change in instantaneous pain intensity 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.
Time frame: Day 0: before first application, then 5 minutes, 10 minutes, and 60 minutes after first application.
Change in global pain intensity over the study period
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.
Time frame: Day 0 to Day 6 ± 1 day or early termination.
Change in swallowing discomfort
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.
Time frame: Day 0 to Day 6 ± 1 day or early termination.
Patient global assessment of effectiveness
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.
Time frame: Day 6 ± 1 day or early termination.
Evolution of associated clinical signs
Change in associated signs reported or observed during the study, including fever, headache, and other associated symptoms.
Time frame: Day 0 to Day 6 ± 1 day or early termination
Adverse events, serious adverse events, incidents, and device deficiencies
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.
Time frame: From inclusion to Day 6 ± 1 day or early termination.
Started Mar 2026 (actual). Primary completion is estimated for Apr 2027, 13 months after the start.
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