Mouth SoresNCT06741280
Post-marketing Study for the Evaluation of Profilm Mouth Sores
A study testing Profilm Mouth Sores in people with Mouth Sores, run by i+Med S.Coop. at 1 site in Spain.
Trial summary
The study aims to assess the effect of Profilm Mouth Sores treatment for relieving symptoms caused by mouth sores. It will involve 35 participants and last around 14 days or until the sores heal, with three daily applications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mouth Sores
- What is being tested?
- Profilm Mouth 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 12 May 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
- Male / female / aged 18 years or older.
- Presence of an ulcer on the oral mucosa, 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.
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 for oral conditions.
- 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 Mouth Sores
The study aims to assess the effect of Profilm Mouth Sores treatment for relieving symptoms caused by mouth sores. It will involve 35 participants and last around 14 days or until the sores heal, with three daily applications. A dermatology specialist will evaluate the results through tests and examinations of the treated area.
- Conditions
- Mouth Sores
- Being tested
- Profilm Mouth Sores
- Keywords
- Ulcers, Recurrent aphthous stomatitis, Oral ulcers, Mouth ulcers, Mouth sores, Sore
- Medical subject headings
- Oral Ulcer, Ulcer, Stomatitis, Aphthous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Profilm Mouth SoresDevice
Daily applications of the product as soon as a mouth sore appears, until its complete disappearance or healing, 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 Mouth Sores | Experimental | To evaluate the efficacy and safety of the Profilm Mouth Sores for the treatment of mouth sores. Receives: Device: Profilm Mouth 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.
For the evaluation of effectiveness, a 0 to 10 EVA scale is used (where 0 = no pain / 10 = severe or unbearable pain).
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, in terms of the incidence of serious adverse events.
Measured: Through study completion, apprroximately 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start13 Dec 2022
- Primary completion15 Dec 2022
- Study completion12 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mouth 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
- Post-marketing, prospective, within-subject controlled clinical trial.
- 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
- NCT06741280
- Sponsor's protocol ID
- PROFILM AFTAS-PIC01-2022
- Status last verified
- Apr 2025
- First submitted
- 11 Dec 2024
- Last updated
- 25 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 25 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 Mouth Sores
- ClinicalTrials.gov ID
- NCT06741280
- Acronym / sponsor ID
- PROFILM AFTAS-PIC01-2022
- Conditions
- Mouth Sores
- Keywords
- Ulcers, Recurrent aphthous stomatitis, Oral ulcers, Mouth ulcers, Mouth sores, Sore
- 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
- 12 May 2023 (actual)
- First posted
- 18 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.
The study aims to assess the effect of Profilm Mouth Sores treatment for relieving symptoms caused by mouth sores. It will involve 35 participants and last around 14 days or until the sores heal, with three daily applications. A dermatology specialist will evaluate the results through tests and examinations of the treated area.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Post-marketing, prospective, within-subject controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Profilm Mouth Sores | Experimental | Device: Profilm Mouth SoresTo evaluate the efficacy and safety of the Profilm Mouth Sores for the treatment of mouth sores. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male / female / aged 18 years or older.
- Presence of an ulcer on the oral mucosa, 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.
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 for oral conditions.
- 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 Mouth SoresDaily applications of the product as soon as a mouth sore appears, until its complete disappearance or healing, 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 Mouth 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.
For the evaluation of effectiveness, a 0 to 10 EVA scale is used (where 0 = no pain / 10 = severe or unbearable pain).
Serious adverse events.
Time frame: Through study completion, apprroximately 2 weeks.
Evaluate the safety of the treatment, in terms of the incidence of serious adverse events.
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 25 Apr 2025.
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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 Mouth Sores in people with Mouth 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 5 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 25 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 25 Apr 2025.