Post-marketing Study for the Evaluation of Profilm Cold Sores

NCT06734728 | Completed

• 1 other identifier: PROFILM HERPES-PIC01-2022
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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).

Conditions

Cold Sores

Keywords

Herpes; Oral herpes simplex; Oral ulcer

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Secondary Outcomes (1)

• Evaluation of the treatment based on lesion size.

  At baseline, in 24 hours, in 3 days, in 7 days and in 14 days.

Other Outcomes (7)

• Changes in the intensity and severity of the symptoms.

  At baseline, in 24 hours, in 3 days, in 7 days and in 14 days.

• Degree of protection-hygiene provided by the treatment.

  At the conclusion of the study, approximately 2 weeks later.

• Evaluation of the visibility-noticeability of the outbreak.

  At the conclusion of the study, approximately 2 weeks later.

Study Arms (1)

Profilm Cold Sores

EXPERIMENTAL

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

Interventions

Profilm Cold Sores DEVICE

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).

Profilm Cold Sores

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• i+Med S.Coop.: lead
• Dr. Goya Análisis, SL.: collaborator
• Centro Médico Complutense Grupo Virtus: collaborator

Study Sites (1)

Centro Médico Complutense Grupo Virtus

Alcalá de Henares, Madrid, 28805, Spain

Location

MeSH Terms

Conditions

Herpes Labialis; Herpes Simplex; Stomatitis, Herpetic; Oral Ulcer

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Stomatitis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Intrasubject control

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 16, 2024
• Study Start: December 13, 2022
• Primary Completion: December 15, 2022
• Study Completion: March 29, 2023
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

ES (1)