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Evaluation of a Combination of Two Medical Devices and One Device Use in the Treatment of Toenail Onychomycosis
Sponsor: Swiss Footcare Laboratories - Poderm Professional
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
44
Start Date
2024-09
Completion Date
2025-01
Last Updated
2024-07-24
Healthy Volunteers
Yes
Conditions
Interventions
Sérum PURIFIANT
Application of Sérum PURIFIANT only, twice daily during 112 days
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