NCT06175013

Evaluation of a Combination of Two Medical Devices and One Device Use in the Treatment of Toenail Onychomycosis

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Swiss Footcare Laboratories - Poderm Professional · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Onychomycosis

Interventions

Type	Name	Description
DEVICE	Sérum PURIFIANT	Application of Sérum PURIFIANT only, twice daily during 112 days
DEVICE	Sérum PURIFIANT in association Sérum BOOSTER	Application of Sérum PURIFIANT twice daily during 112 days AND Application of Sérum BOOSTER before the Serum PURIFIANT, twice weekly

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2023-12-18
• Last updated: 2024-07-24