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

NCT06175013 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-07-24

No results posted yet for this study

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.

Conditions

  • Onychomycosis

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

Sponsors & Collaborators

  • Swiss Footcare Laboratories - Poderm Professional

    lead INDUSTRY

Principal Investigators

  • Aslham DOARIKA · Insight Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-30
Primary Completion
2025-01-31
Completion
2025-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06175013 on ClinicalTrials.gov