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

NCT05959824 | Unknown

• 1 other identifier: DNT2022-01
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Aphthous Ulcer

Keywords

aphthous ulcer; canker sores; aphthous stomatitis; Topical oral gel

Outcome Measures

Primary Outcomes (1)

• VAS score

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

  3xday, 30 minutes after each application for 7 days

Secondary Outcomes (7)

• Daily pain VAS score

  5, 10, 15 and 30 minutes after the first (morning) application of the gel, from baseline up to day 7

• Pain disappearance

  Daily assessments from baseline up to day 7

• Pain free patients percentage

  Daily assessments from baseline up to day 7

• Ulcers reduction

  Daily assessments from baseline up to day 7

• Lesions healing percentage

  Daily assessments from baseline up to day 7

Study Arms (2)

Group 1

EXPERIMENTAL

Treatment with OR-AT0222

Device: OR-AT0222

Group 2

PLACEBO COMPARATOR

Treatment with Placebo

Other: Placebo

Interventions

OR-AT0222 DEVICE

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.

Group 1

Placebo OTHER

Topical placebo viscous gel will be used 3 times a day away from the main meals (breakfast lunch and dinner) for 7 days.

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• Devintec Sagl: lead
• Meditrial SrL: collaborator

Study Sites (1)

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

Rome, 00161, Italy

RECRUITING

MeSH Terms

Conditions

Stomatitis, Aphthous

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Umberto Romeo

CONTACT

+390649976611; umberto.romeo@uniroma1.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, double blind, placebo controlled clinical study.

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: July 25, 2023
• Study Start: May 8, 2023
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: July 25, 2023

Record last verified: 2023-07

Locations

IT (1)