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

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.

Study Overview

• Status: Recruiting
• Conditions: Sore Throat; Oral Lichen Planus; Oral Pain; Aphthous Ulcer; Minor Mouth Lesion
• Intervention / Treatment: Device: OROSEDAL

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.

• Study Type: Observational
• Enrollment (Estimated): 124

Contacts and Locations

• Study Contact: Name: Renaud Urbinelli; Phone Number: +33756882093; Email: etudes@clin-experts.fr

Study Locations

• France
  • Multiple Locations, France
    • Recruiting
    • Multiples facilities
    • Contact: Renaud Urbinelli; Phone Number: +33756882093; Email: etudes@clin-experts.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients treated with OROSEDAL; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1 evening

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	From inclusion to Day 6 ± 1 day or early termination.

Collaborators and Investigators

• Sponsor: Laboratoires Elerte
• Collaborators: Clin-Experts
• Investigators: Principal Investigator: Dominique DELSART

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: May 27, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: sore throat; PMCF; real-world evidence; aphthous ulcer; mouth ulcer; oral lesion; swallowing discomfort
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Stomatitis; Skin and Connective Tissue Diseases; Lichen Planus; Lichen Planus, Oral; Pharyngitis; Oral Ulcer; Stomatitis, Aphthous
• Other Study ID Numbers: 2025-A00279-40

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No