OnychomycosisNCT06175013
Evaluation of a Combination of Two Medical Devices and One Device Use in the Treatment of Toenail Onychomycosis
A study testing Sérum PURIFIANT and Sérum PURIFIANT in association Sérum BOOSTER in people with Onychomycosis, run by Swiss Footcare Laboratories - Poderm Professional at 1 site in Mauritius.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Onychomycosis
- What is being tested?
- Sérum PURIFIANT and Sérum PURIFIANT in association Sérum BOOSTER
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteMauritius
- Study dates
- 12 Nov 2024to 10 Jun 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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 contour with severe lesions
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- Patient having used any systemic antifungal treatment in the last 6 months before inclusion.
- Patient having used any topical antifungal treatment in the last 3 months before inclusion.
- Patient with a condition or receiving a medication which, in the investigator's judgment, put the patient at undue risk.
- Patient suffering from serious or progressive diseases (to investigator's discretion) such as uncontrolled diabetes, peripheral circulatory disease, HIV, lichen planus, immunosuppressive pathology, chronic venous insufficiency, Peripheral Arterial Obstructive Disease, delay or lack of ungual growth …
- Patient with cutaneous pathology on studied zone (onychogryphosis, congenital ungual deformation, toe deformation or of the foot, Hallux Valgus, Hallux rigidus, Hallux extensus, toe claws or other pathologies than onychomycosis like angioma, dermatitis…).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Monocentric, Randomized, "Evaluator Blinded" Clinical Investigation to Evaluate the Efficacy and Safety of a Combination of Two Medical Devices and One Device Use in the Treatment of Toenail Onychomycosis
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.
Read more
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.
Read the detailed description
Onychomycosis is a fungal infection of the nail apparatus that causes discoloration, thickening, and separation from the nail bed.
It is primarily caused by dermatophytes, which are infectious fungi that feed on the keratin present in the skin, hair and nails. Onychomycosis has several clinical presentations, including distal and lateral subungual onychomycosis which is the most common form, proximal subungual onychomycosis, superficial white onychomycosis, and total dystrophic onychomycosis.
Onychomycosis affects toenails more often than fingernails because of their slower growth, reduced blood supply, and frequent confinement in dark, moist environments. (1) The severity of onychomycosis can be described as mild, moderate, or severe. Published studies will assign a label of mild-moderate disease if less than approximately 60% of the nail is showing symptoms.
Onychomycosis is the most common nail infection worldwide occurring in 10% of the general population but is more common in older adults. Despite treatment, the recurrence rate of onychomycosis is 10% to 50% as a result of reinfection or lack of mycotic cure.
Topical drugs for onychomycosis generally come in the form of lacquers or solutions directly applied to the surface of the nail.
The principal aim of this study is to evaluate the efficacy of the tested products in medium to moderate onychomycosis after 112 days of treatments. For this study, 44 patients (22 patients per group) presenting at least one infected toenail will be included to reach this objective.
- Conditions
- Onychomycosis
- Being tested
- Sérum PURIFIANT, Sérum PURIFIANT in association Sérum BOOSTER
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sérum PURIFIANTDevice
Application of Sérum PURIFIANT only, twice daily during 112 days
Sérum PURIFIANT in association Sérum BOOSTERDevice
Application of Sérum PURIFIANT twice daily during 112 days AND Application of Sérum BOOSTER before the Serum PURIFIANT, twice weekly
| Study group | Role | What they receive |
|---|---|---|
| Group 1 : Sérum Mycose des ongles PURIFIANT | Experimental | Participant will apply Sérum PURIFIANT on the affected toenail, twice daily during the 112 days of the study. Receives: Device: Sérum PURIFIANT |
| Group 2 : Sérum Mycose des onglesPURIANT associated with Sérum Mycose des ongles BOOSTER | Experimental | Participant will apply Sérum PURIFIANT on the affected toenail, twice daily during the 112 days of the study.
They will also apply Sérum BOOSTER, twice weekly before the Sérum PURIFIANT. Receives: Device: Sérum PURIFIANT in association Sérum BOOSTER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of healthy surface
The effect of the products on percentage of healthy surface will be evaluated at D112 by the mean variation from baseline in the group using a combination of two devices (Sérum PURIFIANT + Sérum BOOSTER).
Evaluation is done in blind by digital analysis of photographs of the infected toenail.
Measured: Day 0, Day 112
Secondary outcomes (11)
Percentage of healthy surface in group 1
The effect of the product on percentage of healthy surface will be evaluated at D112 by the mean variation from baseline in the group using only one device (Sérum PURIFIANT).
Measured: Day 0, Day 112
Percentage of healthy surface comparison
The effect of the products on percentage of healthy surface will be evaluated at D112 by comparing mean variation from baseline between the two groups.
Measured: Day 0, Day 112
Onychomycosis
The effect of the product on onychomycosis improvement will be evaluated at D0 and 112 days after treatment, on a scale from 0 normal to 3 severe.
The effect of the products on clinical parameters will be evaluated by comparing mean variation from D0 within group and between the two groups.
Measured: Day 0, Day 112
Onycholysis
The effect of the product on onycholysis improvement will be evaluated at D0 and 112 days after treatment, on a scale from 0 normal to 3 severe The effect of the products on clinical parameters will be evaluated by comparing mean variation from D0 within group and between the two groups.
Measured: Day 0, Day 112
Nail microcacking
The effect of the product on nail microcacking improvement will be evaluated at D0 and 112 days after treatment. Number of nail microcracking will be collected.
The effect of the products on clinical parameters will be evaluated by comparing mean variation from D0 within group and between the two groups.
Measured: Day 0, Day 112
Nail opacity
The effect of the product on nail opacity improvement will be evaluated at D0 and 112 days after treatment, on a scale from 0 transparent to 4 Very opaque The effect of the products on clinical parameters will be evaluated by comparing mean variation from D0 within group and between the two groups.
Measured: Day 0, Day 112
KOH staining
Percentage of patients with positive KOH staining at the screening visit and 112 days after treatment in each group and compared between the two groups.
Measured: Day 0, Day 112
QoL
Percentage of patient with an improvement of their quality of life (QoL) by analysis of NailQoL patient answers at D0 and 112 days after treatment in each group and compared between the two groups.
Measured: Day 0, Day 112
Patient questionnaire
Analysis of the answers to the patient questionnaire regarding effectiveness, tolerance, and acceptability of the investigational devices 112 days after treatment in each group. Answer will be on a scale from Totally agree to totally disagree
Measured: Day 0, Day 112
Tolerance
Products tolerance will be assessed by the investigator and the patient at D112 on a 4 points scale from verry bad tolerance to very good tolerance
Measured: Day 0, Day 112
Adverse event
Products safety will be assessed by collection of Adverse Events (AEs) throughout the study. AEs will be summarized and tabulated by severity, causality, action taken and outcome, using descriptive statistics.
Measured: Screening visit, Day 0, Day 112
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start12 Nov 2024
- Primary completion10 Jun 2025
- Study completion10 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OnychomycosisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Footcare Laboratories - Poderm Professional
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aslham DOARIKA, Principal investigator, Insight Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175013
- Sponsor's protocol ID
- 23E2000
- Status last verified
- Jun 2026
- First submitted
- 28 Nov 2023
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Monocentric, Randomized, "Evaluator Blinded" Clinical Investigation to Evaluate the Efficacy and Safety of a Combination of Two Medical Devices and One Device Use in the Treatment of Toenail Onychomycosis
- ClinicalTrials.gov ID
- NCT06175013
- Acronym / sponsor ID
- 23E2000
- Conditions
- Onychomycosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Swiss Footcare Laboratories - Poderm ProfessionalIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 10 Jun 2025 (actual)
- Study completion
- 10 Jun 2025 (actual)
- First posted
- 18 Dec 2023 (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 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.
Detailed description
Onychomycosis is a fungal infection of the nail apparatus that causes discoloration, thickening, and separation from the nail bed.
It is primarily caused by dermatophytes, which are infectious fungi that feed on the keratin present in the skin, hair and nails. Onychomycosis has several clinical presentations, including distal and lateral subungual onychomycosis which is the most common form, proximal subungual onychomycosis, superficial white onychomycosis, and total dystrophic onychomycosis.
Onychomycosis affects toenails more often than fingernails because of their slower growth, reduced blood supply, and frequent confinement in dark, moist environments. (1) The severity of onychomycosis can be described as mild, moderate, or severe. Published studies will assign a label of mild-moderate disease if less than approximately 60% of the nail is showing symptoms.
Onychomycosis is the most common nail infection worldwide occurring in 10% of the general population but is more common in older adults. Despite treatment, the recurrence rate of onychomycosis is 10% to 50% as a result of reinfection or lack of mycotic cure.
Topical drugs for onychomycosis generally come in the form of lacquers or solutions directly applied to the surface of the nail.
The principal aim of this study is to evaluate the efficacy of the tested products in medium to moderate onychomycosis after 112 days of treatments. For this study, 44 patients (22 patients per group) presenting at least one infected toenail will be included to reach this objective.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 : Sérum Mycose des ongles PURIFIANT | Experimental | Device: Sérum PURIFIANTParticipant will apply Sérum PURIFIANT on the affected toenail, twice daily during the 112 days of the study. |
| Group 2 : Sérum Mycose des onglesPURIANT associated with Sérum Mycose des ongles BOOSTER | Experimental | Device: Sérum PURIFIANT in association Sérum BOOSTERParticipant will apply Sérum PURIFIANT on the affected toenail, twice daily during the 112 days of the study. They will also apply Sérum BOOSTER, twice weekly before the Sérum PURIFIANT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| Sérum PURIFIANTApplication of Sérum PURIFIANT only, twice daily during 112 days | Device | Group 1 : Sérum Mycose des ongles PURIFIANT |
| Sérum PURIFIANT in association Sérum BOOSTERApplication of Sérum PURIFIANT twice daily during 112 days AND Application of Sérum BOOSTER before the Serum PURIFIANT, twice weekly | Device | Group 2 : Sérum Mycose des onglesPURIANT associated with Sérum Mycose des ongles BOOSTER |
Primary outcome
Percentage of healthy surface
Time frame: Day 0, Day 112
The effect of the products on percentage of healthy surface will be evaluated at D112 by the mean variation from baseline in the group using a combination of two devices (Sérum PURIFIANT + Sérum BOOSTER). Evaluation is done in blind by digital analysis of photographs of the infected toenail.
11 secondary outcomes
Percentage of healthy surface in group 1
Time frame: Day 0, Day 112
Percentage of healthy surface comparison
Time frame: Day 0, Day 112
Onychomycosis
Time frame: Day 0, Day 112
Onycholysis
Time frame: Day 0, Day 112
Nail microcacking
Time frame: Day 0, Day 112
Nail opacity
Time frame: Day 0, Day 112
KOH staining
Time frame: Day 0, Day 112
QoL
Time frame: Day 0, Day 112
Patient questionnaire
Time frame: Day 0, Day 112
Tolerance
Time frame: Day 0, Day 112
Adverse event
Time frame: Screening visit, Day 0, Day 112
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 24 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Aslham DOARIKA principal investigator
Insight Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sérum PURIFIANT and Sérum PURIFIANT in association Sérum BOOSTER in people with Onychomycosis, run by Swiss Footcare Laboratories - Poderm Professional at 1 site in Mauritius.
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 10 inclusion and 11 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 24 Jun 2026. 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 Mauritius. 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?
Percentage of healthy surface (time frame: Day 0, Day 112). 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 24 Jun 2026.