Clinical trial NCT06175013: Evaluation of a Combination of Two Medical Devices and One Device Use in the Treatment of Toenail Onychomycosis
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Onychomycosis
Lead sponsor: Swiss Footcare Laboratories - Poderm Professional
Sponsor class: INDUSTRY
First posted: 2023-12-18
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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 contour with severe lesions
* 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...).

Primary outcomes:
measure: Percentage of healthy surface
timeFrame: Day 0, Day 112
Secondary outcomes:
measure: Percentage of healthy surface in group 1
timeFrame: Day 0, Day 112
measure: Percentage of healthy surface comparison
timeFrame: Day 0, Day 112
measure: Onychomycosis
timeFrame: Day 0, Day 112
measure: Onycholysis
timeFrame: Day 0, Day 112
measure: Nail microcacking
timeFrame: Day 0, Day 112
measure: Nail opacity
timeFrame: Day 0, Day 112
measure: KOH staining
timeFrame: Day 0, Day 112
measure: QoL
timeFrame: Day 0, Day 112
measure: Patient questionnaire
timeFrame: Day 0, Day 112
measure: Tolerance
timeFrame: Day 0, Day 112
measure: Adverse event
timeFrame: Screening visit, Day 0, Day 112
Other outcomes:
Locations:
Study officials:
affiliation: Insight Research
name: Aslham DOARIKA
role: PRINCIPAL_INVESTIGATOR
References: