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Post-marketing Study for the Evaluation of Profilm Cold Sores

NCT06734728 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-04-01

No results posted yet for this study

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

Interventions

DEVICE

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).

Sponsors & Collaborators

  • Dr. Goya Análisis, SL.

    collaborator INDUSTRY

  • Centro Médico Complutense Grupo Virtus

    collaborator OTHER

  • i+Med S.Coop.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-13
Primary Completion
2022-12-15
Completion
2023-03-29

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06734728 on ClinicalTrials.gov