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Observational Study of OROSEDAL in Sore Throat and Minor Oral Lesions
Sponsor: Laboratoires Elerte
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.
Official title: Relief of Sore Throat Pain or Minor Mouth Lesions, Including Minor Aphthous Ulcers, in Children and Adults Treated With OROSEDAL: An Observational Study
Key Details
Gender
All
Age Range
8 Years - Any
Study Type
OBSERVATIONAL
Enrollment
124
Start Date
2026-03-05
Completion Date
2027-07
Last Updated
2026-06-02
Healthy Volunteers
No
Interventions
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.
Locations (1)
Multiples facilities
Multiple Locations, France