Post-marketing Study for the Evaluation of Profilm Cold Sores

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-13

Study Completion Date

2023-03-29

Brief Summary

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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).

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Detailed Description

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Conditions

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Cold Sores

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Intrasubject control

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Profilm Cold Sores

Intervention Type 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).

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No