NCT06741280

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: i+Med S.Coop. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2022-12-13
• Primary completion: 2022-12-15
• Completion: 2023-05-12
• First posted: 2024-12-18
• Last updated: 2025-04-25

Locations

1 site across 1 country: Spain