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Observational Study of OROSEDAL in Sore Throat and Minor Oral Lesions

NCT07620353 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 124

Last updated 2026-06-02

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Clin-Experts

    collaborator INDUSTRY

  • Laboratoires Elerte

    lead INDUSTRY

Principal Investigators

  • Dominique DELSART

Eligibility

Min Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-05
Primary Completion
2027-04-30
Completion
2027-07-31

Countries

  • France

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07620353 on ClinicalTrials.gov