Post-marketing Study for the Evaluation of Profilm Mouth Sores

i+Med S.Coop.35 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mouth Sores

Interventions

Profilm Mouth SoresDEVICE

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Centro Médico Complutense Grupo Virtus

Alcalá de Henares, Madrid, Spain

Outcomes

Primary Outcomes

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).

Time frame: 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.

Time frame: Through study completion, apprroximately 2 weeks.

Data from ClinicalTrials.gov

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