Observational Study of OROSEDAL in Sore Throat and Minor Oral Lesions

NCT07620353 | Recruiting

• 1 other identifier: 2025-A00279-40
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Sore Throat; Aphthous Ulcer; Oral Lichen Planus; Minor Mouth Lesion; Oral Pain

Keywords

sore throat; aphthous ulcer; mouth ulcer; oral lesion; PMCF; real-world evidence; swallowing discomfort

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Pain responder rate at Day 6 or end of study

  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 global pain intensity over the study period

  Day 0 to Day 6 ± 1 day or early termination.

• Change in swallowing discomfort

  Day 0 to Day 6 ± 1 day or early termination.

• Patient global assessment of effectiveness

  Day 6 ± 1 day or early termination.

Study Arms (1)

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

Interventions

OROSEDAL DEVICE

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.

Patients treated with OROSEDAL

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• Written informed consent from the patient or from one parent for minors.

You may not qualify if:

• More than 3 visible oral mucosal lesions.
• Post-intubation sore throat.
• 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.

Sponsors & Collaborators

• Clin-Experts: collaborator
• Laboratoires Elerte: lead

Study Sites (1)

Multiples facilities

Multiple Locations, France

RECRUITING

MeSH Terms

Conditions

Pharyngitis; Stomatitis, Aphthous; Lichen Planus, Oral; Oral Ulcer

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Stomatitis; Mouth Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Dominique DELSART

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renaud Urbinelli

CONTACT

+33756882093; etudes@clin-experts.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 2, 2026
• Study Start: March 5, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 2, 2026

Record last verified: 2026-05

Locations

FR (1)