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

Launched by SWISS FOOTCARE LABORATORIES - PODERM PROFESSIONAL · Dec 8, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how effective a combination of two special treatments is for people with toenail fungus, known as onychomycosis. The main goal is to see if using these treatments can improve the health of the toenail after 112 days. Participants will be divided into two groups: one group will use a treatment called Sérum PURIFIANT twice a day, while the second group will use Sérum PURIFIANT twice a day along with another treatment called Sérum BOOSTER twice a week. In total, 44 patients who have at least one infected toenail will take part in the study.

To be eligible for the trial, participants must be over 18 years old, in good general health, and able to follow the treatment plan. They should have a mild to moderate type of toenail fungus that does not affect the nail's growth or cause severe damage. Importantly, women who can become pregnant need to use birth control during the study. Participants can expect to apply the treatments as directed and will have regular check-ins to monitor their progress. This trial is not currently recruiting, but it aims to provide helpful information on treating toenail fungus effectively.

Gender

ALL

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 \<2/3 of the tablet)
• • Patient with slight to moderate impact of thickness of the nail and no deformation of the nail.
• • Patient with slight to moderate impact of thickness of the nail and no deformation of the nail.
• • Patient with positive KOH staining.
• • Women of childbearing potential should use an accepted contraceptive regimen (to investigator's discretion) since at least 12 weeks before the beginning of the study, during all the study.
• Exclusion Criteria:
• • Pregnant or nursing woman or planning a pregnancy during the investigation.
• • Patient considered by the investigator likely to be non-compliant with the protocol.
• • Patient enrolled in another clinical trial during the test period.
• • Patient having a known allergy or hypersensitivity to one of the constituents of the tested products.
• • Patient with unstructured nail, severe microcracking or severe onycholysis.
• • Patient with nails and nails contour with severe lesions
• • Patient having used any systemic antifungal treatment in the last 6 months before inclusion.
• • Patient having used any topical antifungal treatment in the last 3 months before inclusion.
• • Patient with a condition or receiving a medication which, in the investigator's judgment, put the patient at undue risk.
• • Patient suffering from serious or progressive diseases (to investigator's discretion) such as uncontrolled diabetes, peripheral circulatory disease, HIV, lichen planus, immunosuppressive pathology, chronic venous insufficiency, Peripheral Arterial Obstructive Disease, delay or lack of ungual growth ...
• • Patient with cutaneous pathology on studied zone (onychogryphosis, congenital ungual deformation, toe deformation or of the foot, Hallux Valgus, Hallux rigidus, Hallux extensus, toe claws or other pathologies than onychomycosis like angioma, dermatitis...).