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NOT YET RECRUITING
NCT06175013
NA

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

Sponsor: Swiss Footcare Laboratories - Poderm Professional

View on ClinicalTrials.gov

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

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