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RECRUITING
NCT07620353

Observational Study of OROSEDAL in Sore Throat and Minor Oral Lesions

Sponsor: Laboratoires Elerte

View on ClinicalTrials.gov

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

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.

Locations (1)

Multiples facilities

Multiple Locations, France