Post-marketing Study for the Evaluation of Profilm Cold Sores

i+Med S.Coop.35 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cold Sores

Interventions

Profilm Cold SoresDEVICE

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Centro Médico Complutense Grupo Virtus

Alcalá de Henares, Madrid, Spain

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Through study completion, apprroximately 2 weeks.

Secondary Outcomes

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

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

Data from ClinicalTrials.gov

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