Cold SoresNCT06734728
Post-marketing Study for the Evaluation of Profilm Cold Sores
A study testing Profilm Cold Sores in people with Cold Sores, run by i+Med S.Coop. at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cold Sores
- What is being tested?
- Profilm Cold Sores
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSpain
- Study dates
- 13 Dec 2022to 29 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Centro Médico Complutense Grupo Virtus
Alcalá de Henares, Madrid, 28805
About this study
Official title: Post-marketing Study for the Evaluation of the Efficacy and Safety of Profilm Cold Sores
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
- Being tested
- Profilm Cold Sores
- Keywords
- Herpes, Oral herpes simplex, Oral ulcer
- Medical subject headings
- Herpes Labialis, Herpes Simplex, Stomatitis, Herpetic, Oral Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Profilm Cold Sores | Experimental | Participants will use Profil Cold Sores daily as soon as the first symptoms of a new outbreak appear and until the outbreak is resolved. Receives: Device: Profilm Cold Sores |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through study completion, apprroximately 2 weeks.
Secondary outcomes (1)
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
Measured: At baseline, in 24 hours, in 3 days, in 7 days and in 14 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start13 Dec 2022
- Primary completion15 Dec 2022
- Study completion29 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cold SoresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intrasubject control
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- i+Med S.Coop.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dr. Goya Análisis, SL., Centro Médico Complutense Grupo Virtus
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734728
- Sponsor's protocol ID
- PROFILM HERPES-PIC01-2022
- Status last verified
- Mar 2025
- First submitted
- 11 Dec 2024
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Study for the Evaluation of the Efficacy and Safety of Profilm Cold Sores
- ClinicalTrials.gov ID
- NCT06734728
- Acronym / sponsor ID
- PROFILM HERPES-PIC01-2022
- Conditions
- Cold Sores
- Keywords
- Herpes, Oral herpes simplex, Oral ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- i+Med S.Coop.Industry (pharma, biotech, devices)
- Collaborators
- Dr. Goya Análisis, SL., Centro Médico Complutense Grupo Virtus
- Study start
- 13 Dec 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 29 Mar 2023 (actual)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intrasubject control
| Arm | Type | Receives |
|---|---|---|
| Profilm Cold Sores | Experimental | Device: Profilm Cold SoresParticipants will use Profil Cold Sores daily as soon as the first symptoms of a new outbreak appear and until the outbreak is resolved. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Profilm Cold SoresThe 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). | Device | Profilm Cold Sores |
Primary outcome
Confirm the effectiveness of the treatment in terms of pain relief, using an EVA scale.
Time frame: At baseline, in 24 hours, in 3 days, in 7 days and in 14 days.
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.
Serious adverse events.
Time frame: Through study completion, apprroximately 2 weeks.
Evaluate the safety of the treatment related to the product, in terms of the incidence of serious adverse events during the treatment.
1 secondary outcome
Evaluation of the treatment based on lesion size.
Time frame: At baseline, in 24 hours, in 3 days, in 7 days and in 14 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
Related trials for Cold Sores
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Profilm Cold Sores in people with Cold Sores, run by i+Med S.Coop. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirm the effectiveness of the treatment in terms of pain relief, using an EVA scale. (time frame: At baseline, in 24 hours, in 3 days, in 7 days and in 14 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.