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Devintec OR-AT0222 Oral Gel for the Treatment of Canker Sores: A Double Blind, Randomized, Placebo Controlled Clinical Investigation

Primary Purpose

Recurrent Aphthous Ulcer

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
OR-AT0222
Placebo
Sponsored by
Devintec Sagl
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Aphthous Ulcer focused on measuring aphthous ulcer, canker sores, aphthous stomatitis, Topical oral gel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: >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 Exclusion Criteria: 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

Sites / Locations

  • Policlinico "Umberto I" - U.O.C. di Odontoiatria Pediatrica ed OdontostomatologiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group 1

Group 2

Arm Description

Treatment with OR-AT0222

Treatment with Placebo

Outcomes

Primary Outcome Measures

VAS score
Mean daily pain VAS score of the treatment group vs placebo.

Secondary Outcome Measures

Daily pain VAS score
Daily pain VAS score at different time points
Pain disappearance
Mean days to pain disappearance in the treatment group respect to placebo
Pain free patients percentage
Percentage of patients who will report to be pain free according to the VAS scale
Ulcers reduction
Reduction of the number of ulcers respect to baseline
Lesions healing percentage
Percent of lesions with complete healing
Pain reduction
Reduction of pain (immediate relief on application, no burning sensation, measurement of how many days pain persists)
Safety
Number of Adverse Events and Serious Adverse Events

Full Information

First Posted
July 17, 2023
Last Updated
July 17, 2023
Sponsor
Devintec Sagl
Collaborators
Meditrial SrL
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1. Study Identification

Unique Protocol Identification Number
NCT05959824
Brief Title
Devintec OR-AT0222 Oral Gel for the Treatment of Canker Sores: A Double Blind, Randomized, Placebo Controlled Clinical Investigation
Official Title
Devintec OR-AT0222 Oral Gel for the Treatment of Canker Sores: A Double Blind, Randomized, Placebo Controlled Clinical Investigation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Devintec Sagl
Collaborators
Meditrial SrL

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Aphthous Ulcer
Keywords
aphthous ulcer, canker sores, aphthous stomatitis, Topical oral gel

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, double blind, placebo controlled clinical study.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Treatment with OR-AT0222
Arm Title
Group 2
Arm Type
Placebo Comparator
Arm Description
Treatment with Placebo
Intervention Type
Device
Intervention Name(s)
OR-AT0222
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Topical placebo viscous gel will be used 3 times a day away from the main meals (breakfast lunch and dinner) for 7 days.
Primary Outcome Measure Information:
Title
VAS score
Description
Mean daily pain VAS score of the treatment group vs placebo.
Time Frame
3xday, 30 minutes after each application for 7 days
Secondary Outcome Measure Information:
Title
Daily pain VAS score
Description
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
Title
Pain disappearance
Description
Mean days to pain disappearance in the treatment group respect to placebo
Time Frame
Daily assessments from baseline up to day 7
Title
Pain free patients percentage
Description
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
Title
Ulcers reduction
Description
Reduction of the number of ulcers respect to baseline
Time Frame
Daily assessments from baseline up to day 7
Title
Lesions healing percentage
Description
Percent of lesions with complete healing
Time Frame
Daily assessments from baseline up to day 7
Title
Pain reduction
Description
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
Title
Safety
Description
Number of Adverse Events and Serious Adverse Events
Time Frame
From baseline up to day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Umberto Romeo
Phone
+390649976611
Email
umberto.romeo@uniroma1.it
Facility Information:
Facility Name
Policlinico "Umberto I" - U.O.C. di Odontoiatria Pediatrica ed Odontostomatologia
City
Rome
ZIP/Postal Code
00161
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Umberto Romeo, MD, DDS, PhD
Phone
+39 0649976611
Email
umberto.romeo@uniroma1.it

12. IPD Sharing Statement

Learn more about this trial

Devintec OR-AT0222 Oral Gel for the Treatment of Canker Sores: A Double Blind, Randomized, Placebo Controlled Clinical Investigation

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