Post-marketing Study for the Evaluation of Profilm Mouth Sores

Post-marketing Study for the Evaluation of the Efficacy and Safety of Profilm Mouth Sores

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.

Study Overview

• Status: Completed
• Conditions: Mouth Sores
• Intervention / Treatment: Device: Profilm Mouth Sores

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Comunidad de Madrid
    • Alcalá de Henares, Comunidad de Madrid, Spain, 28805
      • Centro Médico Complutense Grupo Virtus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Profilm Mouth Sores; To evaluate the efficacy and safety of the Profilm Mouth Sores for the treatment of mouth sores.	Device: Profilm Mouth Sores; Daily applications of the product as soon as a mouth sore 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 (a maximum of 3-4 applications).

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mild adverse events.	Evaluate the incidence of other mild and transient adverse events related to the product.	Through study completion, apprroximately 2 weeks.
Healin time and lesion size.	Reduction in healing time and extent of the ulcer. Mean healing time of the lesion ≤ 14 days or % of patients with complete healing ≥ 70% at one week.	At baseline, in 24 hours, in 3 days, in 7 days and in 14 days.
Global treatment assessment by participants.	Global treatment assessment questionnaires will evaluate the effectiveness of the treatment on a scale from 0 to 10 (where 0 = no response or not satisfied at all, and 10 = excellent response or exceptionally satisfied).	At the conclusion of the study, approximately 2 weeks later.
Number, size, and location of sores	Determination of the number, size, and location of sores, as well as difficulty eating and/or drinking.	At baseline, in 24 hours, in 3 days, in 7 days and in 14 days.

Collaborators and Investigators

• Sponsor: i+Med S.Coop.
• Collaborators: Dr. Goya Análisis, SL.; Centro Médico Complutense Grupo Virtus

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2022
• Primary Completion (Actual): December 15, 2022
• Study Completion (Actual): May 12, 2023

Study Registration Dates

• First Submitted: December 11, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): December 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 25, 2025
• Last Update Submitted That Met QC Criteria: April 23, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Recurrent aphthous stomatitis; Ulcers; Oral ulcers; Mouth sores; Mouth ulcers; Sore
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Oral Ulcer
• Other Study ID Numbers: PROFILM AFTAS-PIC01-2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No