Skip to main content
OpenTrials
Completed

NCT Number: NCT06741280

Post-marketing Study for the Evaluation 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mouth Sores Mouth Diseases Oral Ulcer Pathologic Processes Pathological Conditions, Signs and Symptoms Stomatitis Stomatitis, Aphthous Stomatognathic Diseases Ulcer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Médico Complutense Grupo Virtus

Alcalá de Henares, Madrid, 28805, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. Confirm the effectiveness of the treatment in terms of pain relief, using an EVA scale.

    Time frame: 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).

  2. Serious adverse events.

    Time frame: Through study completion, apprroximately 2 weeks.

    Evaluate the safety of the treatment, in terms of the incidence of serious adverse events.

Other outcomes

  1. Mild adverse events.

    Time frame: Through study completion, apprroximately 2 weeks.

    Evaluate the incidence of other mild and transient adverse events related to the product.

  2. Healin time and lesion size.

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

    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.

  3. Global treatment assessment by participants.

    Time frame: At the conclusion of the study, approximately 2 weeks later.

    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).

  4. Number, size, and location of sores

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

    Determination of the number, size, and location of sores, as well as difficulty eating and/or drinking.

Sponsors and collaborators

Lead sponsor

i+Med S.Coop.

Industry

Collaborators

  • Centro Médico Complutense Grupo Virtus
  • Dr. Goya Análisis, SL.

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Dec 18, 2024
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.