Observational Study of OROSEDAL in Sore Throat and Minor Oral Lesions

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.

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.