Effectiveness and Safety of Nailner Brush 2in1 in Onychomycosis

Karo Pharma

Status: Completed

Conditions: Onychomycosis

Treatments: Device: topical treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT05560841

21E4142

Details and patient eligibility

About

Evaluate the effectiveness of Nailner Brush 2-in-1 in the treatment of onychomycosis based on the blinded evaluation of the percentage of healthy nail surface after 6 months of treatment compared to baseline.

Enrollment: 50 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient having given freely her/his informed, written consent.
• Patient having a good general health.
• Age: between 18 and 70 years.
• Patient with superficial onychomycosis or light to moderate distolateral onychomycosis (without matrix involvement and involvement from 10 to 60%) on at least one great toenail.
• Patient with positive KOH staining.
• Patient cooperative and aware of the device 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 their/his/her consent.
• Patient who agrees to refrain from receiving pedicure, artificial nails and/or cosmetic nail varnish or other medication on the nail being treated for the entire study duration.
• Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 4 weeks before screening visit and during all the study.

Exclusion criteria

• Pregnant, breastfeeding woman or woman planning a pregnancy during the study;
• Patient enrolled in another clinical trial or which exclusion period is not over.
• Patient having used any systemic antifungal treatment in the last 6 months before screening and/or any topical antifungal treatment in the last months before screening visit.
• Patient with a condition or receiving a medication which, in the investigator's judgment, put the patient at undue risk;
• Patient suffering from a severe or progressive disease (at investigator's discretion) such as uncontrolled diabetes, peripheral circulatory disease, poor blood circulation HIV, psoriasis, lichen planus, immunosuppressive pathology, moderate and high risk obesity (BMI ≥30);
• Patient having a known allergy or hypersensitivity to one of the constituents of the investigational device.
• Patient with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis...).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Nailner 2 in 1

Experimental group

Description:

Nailner Brush 2-in-1 (5ml) Liquid solution in glass bottle with a brush applicator Topical application twice a day during 4 weeks then once a day until 6 months

Treatment:

Device: topical treatment