Post-marketing Study for the Evaluation of Profilm Mouth Sores

Not Applicable

Completed

• Conditions: Mouth Sores

• Registration Number: NCT06741280
• Lead Sponsor: i+Med S.Coop.

Brief Summary

The study aims to assess the effect of Profilm Mouth Sores treatment for relieving symptoms caused by mouth sores. It will involve 35 participants and last around 14 days or until the sores heal, with three daily applications. A dermatology specialist will evaluate the results through tests and examinations of the treated area.

Detailed Description

Aphthous ulcers are small lesions that appear on the soft tissues of the mouth. They are painful, recurrent, non-contagious, and cause difficulties when eating and speaking.

When one or more painful ulcers are present on the oral mucosa with loss of epithelial continuity, it is known as recurrent aphthous stomatitis. It is a pathological process triggered by various factors and an underlying immune alteration, and so far, there is no specific medication that leads to complete healing. The most successful trials have shortened the healing period and lengthened the time between recurrences. The most widespread treatments due to their effectiveness, safety, accessibility, and ease of use are local non-pharmacological treatments. In this context is Profilm Oral Canker Sores, for topical application, which forms a protective film that relieves pain caused by sensitizing agents such as saliva. It also creates a microenvironment that promotes the natural healing of the lesion.

The clinical research carried out corresponds to a post-marketing, prospective, within-subject controlled clinical trial to evaluate the efficacy and safety of a medical product for the treatment of canker sores, during a maximum period of two weeks. The study population will consist of 35 men and women over 18 years old, dermatology patients at the Complutense Medical Center, Virtus group, who wish to relieve symptoms related to the appearance of oral canker sores, and whose sample size has been statistically established in advance.

The treatment will consist of daily applications of the product as soon as an oral ulcer appears, until its complete disappearance or healing, as follows: application every 8 hours, with the possibility of shortening the interval to 6 hours if needed (maximum 3-4 applications).

The primary objective will be to demonstrate the efficacy and therapeutic action of the product in reducing the symptoms and signs of canker sores. The secondary objective will be to determine the tolerance and safety after the use of the medical product.

Study Timeline

• Study Start: 2022-12-13
• Primary Completion: 2022-12-15
• Study Completion: 2023-05-12
• Study First Submitted: 2024-12-11
• Study First Submitted QC: 2024-12-16
• Study First Posted: 2024-12-18
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Male / female / aged 18 years or older.
• Presence of an ulcer on the oral mucosa, regardless of the number of days since its appearance.
• At least 30 days have passed since the last episode.
• Willingness to return for all study-related visits.
• Sufficient willingness and ability, as judged by the investigator, to respond to the questionnaires included in the study.

Exclusion Criteria

• Pregnant women or women in the breastfeeding period.
• Patients undergoing treatment with antiviral medications, hydrocortisone, or other medications.
• Patients with immunodeficiency diseases, such as acquired immunodeficiency syndrome or altered immune activity in the last 7 days.
• Patients undergoing other pharmacological therapy for oral conditions.
• Patients with other oral mucosa diseases simultaneously.
• Known allergy or hypersensitivity to any of the components.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Confirm the effectiveness of the treatment in terms of pain relief, using an EVA scale.	At baseline, in 24 hours, in 3 days, in 7 days and in 14 days.	For the evaluation of effectiveness, a 0 to 10 EVA scale is used (where 0 = no pain / 10 = severe or unbearable pain).
Serious adverse events.	Through study completion, apprroximately 2 weeks.	Evaluate the safety of the treatment, in terms of the incidence of serious adverse events.

Trial Locations

Locations (1)

Centro Médico Complutense Grupo Virtus; 🇪🇸 Alcalá de Henares, Comunidad de Madrid, Spain