Post-marketing Study for the Evaluation of Profilm Cold Sores (NCT06734728) | Clinical Trial Compass
CompletedNot Applicable
Post-marketing Study for the Evaluation of Profilm Cold Sores
Spain35 participantsStarted 2022-12-13
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
2
Serious adverse events.
Timeframe: Through study completion, apprroximately 2 weeks.