← Back to all trials
Completed
NCT06175013
Evaluation of a Combination of Two Medical Devices and One Device Use in the Treatment of Toenail Onychomycosis
Conditions: Onychomycosis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 44
Sponsor: Swiss Footcare Laboratories - Poderm Professional
Location: Insight Research Quatres Bornes
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.
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 \
Source: ClinicalTrials.gov (NCT06175013). StuddyBuddy aggregates publicly available trial information.