Post-marketing Study for the Evaluation of Profilm Mouth Sores

NCT06741280 | Completed

• 1 other identifier: PROFILM AFTAS-PIC01-2022
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Mouth Sores

Keywords

Ulcers; Recurrent aphthous stomatitis; Oral ulcers; Mouth ulcers; Mouth sores; Sore

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Mild adverse events.

  Through study completion, apprroximately 2 weeks.

• Healin time and lesion size.

  At baseline, in 24 hours, in 3 days, in 7 days and in 14 days.

• Global treatment assessment by participants.

  At the conclusion of the study, approximately 2 weeks later.

Study Arms (1)

Profilm Mouth Sores

EXPERIMENTAL

To evaluate the efficacy and safety of the Profilm Mouth Sores for the treatment of mouth sores.

Device: Profilm Mouth Sores

Interventions

Profilm Mouth Sores DEVICE

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).

Profilm Mouth Sores

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• i+Med S.Coop.: lead
• Dr. Goya Análisis, SL.: collaborator
• Centro Médico Complutense Grupo Virtus: collaborator

Study Sites (1)

Centro Médico Complutense Grupo Virtus

Alcalá de Henares, Madrid, 28805, Spain

Location

MeSH Terms

Conditions

Oral Ulcer; Ulcer; Stomatitis, Aphthous

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stomatitis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Post-marketing, prospective, within-subject controlled clinical trial.

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 18, 2024
• Study Start: December 13, 2022
• Primary Completion: December 15, 2022
• Study Completion: May 12, 2023
• Last Updated: April 25, 2025

Record last verified: 2025-04

Locations

ES (1)