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

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).

Study Overview

• Status: Completed
• Conditions: Cold Sores
• Intervention / Treatment: Device: Profilm Cold Sores

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Comunidad de Madrid
    • Alcalá De Henares, Comunidad de Madrid, Spain, 28805
      • Centro Médico Complutense Grupo Virtus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

nclusion Criteria:

• Male / female / aged 18 years or older.
• Presence of a herpes labial outbreak, 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 forrecurrent herpes labial.
• Patients with other oral mucosa diseases simultaneously.
• Known allergy or hypersensitivity to any of the components.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Profilm Cold Sores; Participants will use Profil Cold Sores daily as soon as the first symptoms of a new outbreak appear and until the outbreak is resolved.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious adverse events.	Evaluate the safety of the treatment related to the product, in terms of the incidence of serious adverse events during the treatment.	Through study completion, apprroximately 2 weeks.
Confirm the effectiveness of the treatment in terms of pain relief, using an EVA scale.	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.	At baseline, in 24 hours, in 3 days, in 7 days and in 14 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the treatment based on lesion size.	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	At baseline, in 24 hours, in 3 days, in 7 days and in 14 days.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical assessment of the skin condition by a specialist.	Clinical assessment of the skin condition (localization of the vesicles, extent or lack thereof to the skin, observation of other related factors: fever, muscle pain, lymph node inflammation...).	At baseline, in 24 hours, in 3 days, in 7 days and in 14 days.
Mild adverse events.	Evaluate the incidence of other mild and transient adverse events related to the product.	Through study completion, apprroximately 2 weeks.
Changes in the intensity and severity of the symptoms.	Assessment of the severity-intensity of symptoms (pain, itching, burning or stinging, and tingling) perceived with a score ≤ 4 points on a 0 to 10 scale. (Where 0 = no symptoms / 10 = severe symptoms).	At baseline, in 24 hours, in 3 days, in 7 days and in 14 days.
Degree of protection-hygiene provided by the treatment.	It is done using a scale from 0 to 10, where 0 = no protection and 10 = full protection. A score of ≥ 5 on a scale from 0 to 10 at the end of the treatment will indicate effectiveness.	At the conclusion of the study, approximately 2 weeks later.
Evaluation of the visibility-noticeability of the outbreak.	It will be done using a scale where a score of ≤ 5 on a scale from 0 to 10 at the end of the treatment will indicate effectiveness (where 0 = not noticeable at all and 10 = highly noticeable).	At the conclusion of the study, approximately 2 weeks later.
Global treatment assessment by participants	On a scale from 0 to 10 (where 0 = no response or not satisfied at all, and 10 = excellent response or exceptionally satisfied) after the treatment. A score of ≥ 6 out of 10 will indicate responders.	At the conclusion of the study, approximately 2 weeks later.
Mean duration of the episode	Mean duration of the episode (MDE) due to cold sores (≤ 7 days)	Through study completion, apprroximately 2 weeks

Collaborators and Investigators

• Sponsor: i+Med S.Coop.
• Collaborators: Dr. Goya Análisis, SL.; Centro Médico Complutense Grupo Virtus

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2022
• Primary Completion (Actual): December 15, 2022
• Study Completion (Actual): March 29, 2023

Study Registration Dates

• First Submitted: December 11, 2024
• First Submitted That Met QC Criteria: December 11, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Herpes; Oral ulcer; Oral herpes simplex
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Infections; Virus Diseases; DNA Virus Infections; Skin Diseases; Skin Diseases, Infectious; Herpesviridae Infections; Lip Diseases; Skin Diseases, Viral; Herpes Simplex; Herpes Labialis
• Other Study ID Numbers: PROFILM HERPES-PIC01-2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No