RecruitingNCT07620353

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

Sponsor

Laboratoires Elerte

Enrollment

124 participants

Start Date

Mar 5, 2026

Study Type

OBSERVATIONAL

Conditions

Oral Lichen Planus Sore-throat Oral Pain Aphthous Ulcer Minor Mouth Lesion

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.

Eligibility

Min Age: 8 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called OROSEDAL for people with aphthous ulcer, minor mouth lesion, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 8 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEOROSEDAL

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.