Effectiveness and Safety of Nailner Brush 2in1 in Onychomycosis

NCT ID: NCT05560841

Last Updated: 2023-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-28
• Study Completion Date: 2023-04-10

Brief Summary

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.

Conditions

Onychomycosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nailner 2 in 1

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

Group Type: EXPERIMENTAL

topical treatment

Intervention Type: DEVICE

Topical application of Nailner brush 2in1 for toenail onychomycosis

Interventions

topical treatment

Topical application of Nailner brush 2in1 for toenail onychomycosis

Intervention Type: DEVICE

Eligibility Criteria

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…).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karo Pharma AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pr. Nejib DOSS, MD

Role: PRINCIPAL_INVESTIGATOR

Dermascan

Locations

Private practice

Ben Arous, , Tunisia

Private Practice

Tunis, , Tunisia

Countries

Tunisia

Other Identifiers

21E4142

Identifier Type: -

Identifier Source: org_study_id