Post-marketing Study for the Evaluation of Profilm Mouth Sores

i+Med S.Coop.

Status

Completed

Conditions

Mouth Sores

Treatments

Device: Profilm Mouth Sores

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06741280

PROFILM AFTAS-PIC01-2022

Details and patient eligibility

About

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.

Enrollment

35 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.