New oral spray aims to ease sore throat and canker sores without drugs
NCT ID NCT07620353
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing an oral spray called OROSEDAL to see if it helps relieve pain from sore throats, canker sores, and other minor mouth lesions. About 124 children and adults will use the spray as prescribed and report their pain levels over 6 days. The spray works by forming a protective barrier over the sore area to soothe irritation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- OROSEDAL oral spray (a medical device that forms a protective barrier to soothe irritation)
- What this could lead to
- If successful, this study could confirm that OROSEDAL provides quick pain relief for common sore throats and mouth sores without medication.
- What could go wrong
- This is an observational study with no placebo group, so results may be less reliable. The follow-up is only 6 days, and the device may not work for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 124 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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8 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. * OROSEDAL prescription decided by the investigator before inclusion. * Written informed consent from the patient or from one parent for minors. Exclusion Criteria: * More than 3 visible oral mucosal lesions. * Post-intubation sore throat. * Corticosteroid use ongoing or within 3 days before inclusion. * NSAID use ongoing or within 3 days before inclusion. * Local treatment on the lesion ongoing or within 3 days before inclusion. * Non-opioid analgesics, including paracetamol, ongoing or within 3 days before inclusion, unless continued for at least 24 hours at the same daily dose as during the 24 hours before inclusion. * Weak or strong opioid analgesics ongoing or within 3 days before inclusion. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Multiples facilities
RECRUITINGMultiple Locations, France
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