An interventional study of OR-AT0222 and Placebo in Recurrent Aphthous Ulcer, sponsored by Devintec Sagl. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-25.
Sponsored by Devintec Sagl · Not applicable, Interventional, and Treatment
Canker sore, also known as aphthous stomatitis or ulcers and aphthae, is a common ailment, idiopathic in nature, with recurrent painful aphthous ulcers on the non-keratinized oral mucous membranes.
Recurrent aphthous ulcer has higher prevalence in young adults and the frequency decreases with increasing age. The etiology of aphthous ulcer remains unclear. Other possible factors include trauma, drug use, deficiency in vitamin B12, folic acid, iron, stress, hormonal changes and metabolic diseases. Topical agents such as local antibiotics, local antiseptics, NSAIDs, and corticosteroids are generally prescribed for symptomatic relief. Several approved drug formulations such as pills, mouthwash, sprays and paste such as vitamin B12, chlorhexidine mouthwash, steroid lozenges and local anesthetics are primarily suggested for the treatment of aphthous ulcer. Despite the available local treatments, still sometimes oral canker sores may represent a painful burden for the patient and the gel OR-AT0222 may represent a topical product easy to use, well tolerated and effective local pain reliever, by facilitating the healing of the lesion(s).
The Sponsor, Devintec Sagl, presents OR-AT0222, indicated for the management of canker sores, aphthous stomatitis and small lesions of the mouth. The gel forms a persistent protective film with a "barrier effect" that promotes wound healing and protects the lesions of the oral cavity from contact with external agents, providing pain relief and reducing the risk of further irritation.
Each subject will be asked to sign the Informed Consent Form (ICF). A total of 46 subjects will be enrolled, 23 for each group will be randomized with a 1:1 ratio and allocated to one treatment group (blinded assignment). Group 1: Treatment with OR-AT0222 and Group 2: Treatment with Placebo. The patients will be asked to apply 1-2 drops of the gel on their ulcers three times a day for 7 days and to record the aphthous pain level based on visual analogue scale (VAS) using a number scale from 0 to 10, with 0 no pain at all and 10 the most severe pain. The patients have to refrain from eating and drinking for at least 30 minutes after gel application. The study will also assess tolerability and safety (adverse events). At day 8, the patients will be examined again. Complete healing (the time when the pseudomembrane and the erythematous border disappear) will be confirmed by clinician examination at the end of the treatment period. Reduction of the number of ulcers respect to baseline and percent of lesions with complete healing will be also assessed
63 studies on the registry are indexed under Stomatitis, Aphthous; 17 are open to participants now.
This study's planned enrollment of 46 is above the median of 41 across 54 interventional studies indexed under Stomatitis, Aphthous.
Browse Stomatitis, Aphthous studies →Devintec Sagl is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment with OR-AT0222
Device: OR-AT0222
Treatment with Placebo
Other: Placebo
Topical viscous gel containing tamarind seed polysaccharide and isolated pea proteins will be used 3 times a day away from the main meals (breakfast lunch and dinner) for 7 days.
Topical placebo viscous gel will be used 3 times a day away from the main meals (breakfast lunch and dinner) for 7 days.
VAS score
Mean daily pain VAS score of the treatment group vs placebo.
Time frame: 3xday, 30 minutes after each application for 7 days
Daily pain VAS score
Daily pain VAS score at different time points
Time frame: 5, 10, 15 and 30 minutes after the first (morning) application of the gel, from baseline up to day 7
Pain disappearance
Mean days to pain disappearance in the treatment group respect to placebo
Time frame: Daily assessments from baseline up to day 7
Pain free patients percentage
Percentage of patients who will report to be pain free according to the VAS scale
Time frame: Daily assessments from baseline up to day 7
Ulcers reduction
Reduction of the number of ulcers respect to baseline
Time frame: Daily assessments from baseline up to day 7
Lesions healing percentage
Percent of lesions with complete healing
Time frame: Daily assessments from baseline up to day 7
Pain reduction
Reduction of pain (immediate relief on application, no burning sensation, measurement of how many days pain persists)
Time frame: From baseline up to day 7
Safety
Number of Adverse Events and Serious Adverse Events
Time frame: From baseline up to day 7
Started May 2023 (actual). Primary completion is estimated for Sep 2023, 4 months after the start.
Of 13 interventional studies with no phase under Stomatitis, Aphthous, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 19. This study's planned 4 months is below that.
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