Post-marketing Study for the Evaluation of Profilm Cold Sores

Not Applicable

Completed

• Conditions: Cold Sores

• Registration Number: NCT06734728
• Lead Sponsor: i+Med S.Coop.

Brief 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).

Detailed Description

Herpes labialis is a very common skin condition primarily caused by the Herpes simplex virus type 1, which establishes latent infection in the host for life and can periodically reactivate. Episodes can be frequent, painful, long-lasting, and disfiguring, with significant psychological implications for infected patients and their quality of life. A product for this condition should calm and relieve symptoms before the appearance of cold sores, delay or inhibit the progression of the outbreak, and provide a physical-mechanical barrier to prevent contagion. Although formulations for cold sores have improved over time, none are capable of completely eradicating the virus. Therefore, treatment for this condition is mainly symptomatic, alleviating the most uncomfortable symptoms and pain that usually manifest in the early stages of the outbreak.

In this context, the present study focuses on the already marketed product Profilm Herpes Labial. The research consists of a prospective, post-marketing, intra-subject controlled clinical trial 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. The study population will consist of women and men over 18 years old who wish to relieve the symptoms related to the appearance of cold sores, with the sample size being statistically established in advance. The subjects are volunteers from the general population, patients from the Complutense Medical Center Virtus Group Dermatology, who present cold sores at the time of recruitment.

The study sample will consist of 35 women and men. They will be recruited consecutively, and the treatment will be followed for two weeks.

Study Timeline

• Study Start: 2022-12-13
• Primary Completion: 2022-12-15
• Study Completion: 2023-03-29
• Study First Submitted: 2024-12-11
• Study First Submitted QC: 2024-12-11
• Status Verified: 2025-03
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

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 forrecurrent herpes labial.
• Patients with other oral mucosa diseases simultaneously.
• Known allergy or hypersensitivity to any of the components.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Confirm the effectiveness of the treatment in terms of pain relief, using an EVA scale.	At baseline, in 24 hours, in 3 days, in 7 days and in 14 days.	Pain relief as a significant clinical improvement in the EVA Pain score from 0 to 10 (where 0 = no pain and 10 = unbearable or severe pain) after treatment.
Serious adverse events.	Through study completion, apprroximately 2 weeks.	Evaluate the safety of the treatment related to the product, in terms of the incidence of serious adverse events during the treatment.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the treatment based on lesion size.	At baseline, in 24 hours, in 3 days, in 7 days and in 14 days.	A decrease of at least 50% of the maximum size reached, at the midpoint of the treatment (7 days). Exploratory analysis at 14 days or at the end of the outbreak, with at least an 80% reduction in the extent of the lesion

Trial Locations

Locations (1)

Centro Médico Complutense Grupo Virtus; 🇪🇸 Alcalá De Henares, Comunidad de Madrid, Spain