Evaluation of a Combination of Two Medical Devices and One Device Use in the Treatment of Toenail… (NCT06175013) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of a Combination of Two Medical Devices and One Device Use in the Treatment of Toenail Onychomycosis
Mauritius44 participantsStarted 2024-11-12
Plain-language summary
The goal of this clinical investigation is to evaluate the efficacy of the tested products in medium to moderate onychomycosis after 112 days of treatments.
The main question it aims to answer is the effectiveness of the use of a combination of two investigational devices (Sérum PURIFIANT + Sérum BOOSTER) on the percentage of healthy nail surface after 112 days of treatment.
Participants will apply one or two devices on the affected toenail during the study.
* Patients included on the groupe 1 will use Sérum PURIFIANT only, twice daily.
* Patient included on group 2 will use Sérum PURIFIANT, twice daily associated with Sérum BOOSTER twice weekly.
For this investigation, 44 patients (22 patients per group) presenting at least one infected toenail will be included to reach this objective.
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.
Inclusion Criteria:
* Patient having given freely her/his informed, written consent.
* Patient having a good general health.
* Age: more than 18 years.
* Patient cooperative and aware of the devices' modalities of use and the necessity and duration of the controls so that perfect adhesion to the protocol can be expected.
* Patient being psychologically able to understand information and to give his/her consent.
* Patient with nails superficial onychomycosis on at least one great toenail or light to moderate disto-lateral onychomycosis (without matrix involvement and involvement \<2/3 of the tablet)
* Patient with slight to moderate impact of thickness of the nail and no deformation of the nail.
* Patient with slight to moderate impact of thickness of the nail and no deformation of the nail.
* Patient with positive KOH staining.
* Women of childbearing potential should use an accepted contraceptive regimen (to investigator's discretion) since at least 12 weeks before the beginning of the study, during all the study.
Exclusion Criteria:
* Pregnant or nursing woman or planning a pregnancy during the investigation.
* Patient considered by the investigator likely to be non-compliant with the protocol.
* Patient enrolled in another clinical trial during the test period.
* Patient having a known allergy or hypersensitivity to one of the constituents of the tested products.
* Patient with unstructured nail, severe microcracking or severe onycholysis.
* Patient with nails and nails…
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
Percentage of healthy surface
Timeframe: Day 0, Day 112
Trial details
NCT IDNCT06175013
SponsorSwiss Footcare Laboratories - Poderm Professional