Clinical trial NCT06734728: Post-marketing Study for the Evaluation of Profilm Cold Sores
Official title: Post-marketing Study for the Evaluation of the Efficacy and Safety of Profilm Cold Sores
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cold Sores
Keywords: Herpes
Oral herpes simplex
Oral ulcer
Lead sponsor: i+Med S.Coop.
Sponsor class: INDUSTRY
Collaborators: name: Dr. Goya Análisis, SL.
name: Centro Médico Complutense Grupo Virtus
First posted: 2024-12-16
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intrasubject control
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
measure: Confirm the effectiveness of the treatment in terms of pain relief, using an EVA scale.
timeFrame: At baseline, in 24 hours, in 3 days, in 7 days and in 14 days.
measure: Serious adverse events.
timeFrame: Through study completion, apprroximately 2 weeks.
Secondary outcomes:
measure: Evaluation of the treatment based on lesion size.
timeFrame: At baseline, in 24 hours, in 3 days, in 7 days and in 14 days.
Other outcomes:
measure: Changes in the intensity and severity of the symptoms.
timeFrame: At baseline, in 24 hours, in 3 days, in 7 days and in 14 days.
measure: Degree of protection-hygiene provided by the treatment.
timeFrame: At the conclusion of the study, approximately 2 weeks later.
measure: Evaluation of the visibility-noticeability of the outbreak.
timeFrame: At the conclusion of the study, approximately 2 weeks later.
measure: Global treatment assessment by participants
timeFrame: At the conclusion of the study, approximately 2 weeks later.
measure: Clinical assessment of the skin condition by a specialist.
timeFrame: At baseline, in 24 hours, in 3 days, in 7 days and in 14 days.
measure: Mild adverse events.
timeFrame: Through study completion, apprroximately 2 weeks.
measure: Mean duration of the episode
timeFrame: Through study completion, apprroximately 2 weeks
Locations:
city: Alcalá De Henares
country: Spain
facility: Centro Médico Complutense Grupo Virtus
state: Comunidad de Madrid
Study officials:
References: