MedTrace Logo

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

NCT05959824 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2023-07-25

No results posted yet for this study

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

Interventions

DEVICE

OR-AT0222

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.

OTHER

Placebo

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

Sponsors & Collaborators

  • Meditrial SrL

    collaborator INDUSTRY

  • Devintec Sagl

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-08
Primary Completion
2023-09-30
Completion
2023-09-30

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05959824 on ClinicalTrials.gov