NCT06734728

Post-marketing Study for the Evaluation of Profilm Cold Sores

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

Experimental clinical study with a post-marketing, prospective, intra-subject controlled design to evaluate the efficacy and safety of the use of a medical device for the treatment of cold sores, over a maximum period of two weeks (or until the outbreak has resolved).

Conditions

• Cold Sores

Interventions

Type	Name	Description
DEVICE	Profilm Cold Sores	The treatment will consist of daily applications of the product as soon as the first symptoms of an outbreak appear, and until the outbreak subsides, 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: 2023-03-29
• First posted: 2024-12-16
• Last updated: 2025-04-01

Locations

1 site across 1 country: Spain