Post-marketing Study for the Evaluation of Profilm Cold Sores

i+Med S.Coop.

Status: Completed

Conditions: Cold Sores

Treatments: Device: Profilm Cold Sores

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06734728

PROFILM HERPES-PIC01-2022

Details and patient eligibility

About

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).

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Profilm Cold Sores

Experimental group

Description:

Participants will use Profil Cold Sores daily as soon as the first symptoms of a new outbreak appear and until the outbreak is resolved.

Treatment:

Device: Profilm Cold Sores