Recurrent Aphthous UlcerNCT05959824
Devintec OR-AT0222 Oral Gel for the Treatment of Canker Sores: A Double Blind, Randomized, Placebo Controlled Clinical Investigation
A study testing OR-AT0222 in people with Recurrent Aphthous Ulcer, run by Devintec Sagl at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Aphthous Ulcer
- What is being tested?
- OR-AT0222
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteItaly
- Study dates
- 8 May 2023to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years (male and females)
- Patients have one oral canker sore, at least. Onset within 48 hours
- Patients in good condition with no serious systemic disease
Who cannot join
- Hypersensitivity to any OR-AT0222 ingredients
- Use of any medication to treat the ulcers the previous week before ORAT0222 gel use started or use of local medication or systemic drug during the treatment with OR-AT0222 gel.
- Underlying systemic disease(s) or a history of immunologic disorder(s);
- Taking immunomodulatory agents or systemic nonsteroidal antiinflammatory drugs < 1 month before study commencement;
- Smokers;
- Could not provide written informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Policlinico "Umberto I" - U.O.C. di Odontoiatria Pediatrica ed Odontostomatologia
Rome, 00161
Umberto Romeo, MD, DDS, PhD, +39 0649976611, umberto.romeo@uniroma1.it
About this study
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.
Read the detailed description
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
- Conditions
- Recurrent Aphthous Ulcer
- Being tested
- OR-AT0222, Placebo
- Keywords
- aphthous ulcer, canker sores, aphthous stomatitis, Topical oral gel
- Medical subject headings
- Stomatitis, Aphthous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OR-AT0222Device
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.
PlaceboOther
Topical placebo viscous gel will be used 3 times a day away from the main meals (breakfast lunch and dinner) for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Treatment with OR-AT0222 Receives: Device: OR-AT0222 |
| Group 2 | Placebo comparator | Treatment with Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS score
Mean daily pain VAS score of the treatment group vs placebo.
Measured: 3xday, 30 minutes after each application for 7 days
Secondary outcomes (7)
Daily pain VAS score
Daily pain VAS score at different time points
Measured: 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
Measured: 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
Measured: Daily assessments from baseline up to day 7
Ulcers reduction
Reduction of the number of ulcers respect to baseline
Measured: Daily assessments from baseline up to day 7
Lesions healing percentage
Percent of lesions with complete healing
Measured: 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)
Measured: From baseline up to day 7
Safety
Number of Adverse Events and Serious Adverse Events
Measured: From baseline up to day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start8 May 2023
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Aphthous UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, double blind, placebo controlled clinical study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Devintec Sagl
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Meditrial SrL
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959824
- Sponsor's protocol ID
- DNT2022-01
- Status last verified
- Jul 2023
- First submitted
- 17 Jul 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Devintec OR-AT0222 Oral Gel for the Treatment of Canker Sores: A Double Blind, Randomized, Placebo Controlled Clinical Investigation
- ClinicalTrials.gov ID
- NCT05959824
- Acronym / sponsor ID
- DNT2022-01
- Conditions
- Recurrent Aphthous Ulcer
- Keywords
- aphthous ulcer, canker sores, aphthous stomatitis, Topical oral gel
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Devintec SaglIndustry (pharma, biotech, devices)
- Collaborators
- Meditrial SrL
- Study start
- 8 May 2023 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 25 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Prospective, randomized, double blind, placebo controlled clinical study.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: OR-AT0222Treatment with OR-AT0222 |
| Group 2 | Placebo comparator | Other: PlaceboTreatment with Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >18 years (male and females)
- Patients have one oral canker sore, at least. Onset within 48 hours
- Patients in good condition with no serious systemic disease
Key exclusion criteria (6 listed)
- Hypersensitivity to any OR-AT0222 ingredients
- Use of any medication to treat the ulcers the previous week before ORAT0222 gel use started or use of local medication or systemic drug during the treatment with OR-AT0222 gel.
- Underlying systemic disease(s) or a history of immunologic disorder(s);
- Taking immunomodulatory agents or systemic nonsteroidal antiinflammatory drugs < 1 month before study commencement;
- Smokers;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OR-AT0222Topical 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. | Device | Group 1 |
| PlaceboTopical placebo viscous gel will be used 3 times a day away from the main meals (breakfast lunch and dinner) for 7 days. | Other | Group 2 |
Primary outcome
VAS score
Time frame: 3xday, 30 minutes after each application for 7 days
Mean daily pain VAS score of the treatment group vs placebo.
7 secondary outcomes
Daily pain VAS score
Time frame: 5, 10, 15 and 30 minutes after the first (morning) application of the gel, from baseline up to day 7
Pain disappearance
Time frame: Daily assessments from baseline up to day 7
Pain free patients percentage
Time frame: Daily assessments from baseline up to day 7
Ulcers reduction
Time frame: Daily assessments from baseline up to day 7
Lesions healing percentage
Time frame: Daily assessments from baseline up to day 7
Pain reduction
Time frame: From baseline up to day 7
Safety
Time frame: From baseline up to day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OR-AT0222 in people with Recurrent Aphthous Ulcer, run by Devintec Sagl at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Umberto Romeo (+390649976611, umberto.romeo@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS score (time frame: 3xday, 30 minutes after each application for 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.