Clinical trial NCT05560841: Effectiveness and Safety of Nailner Brush 2in1 in Onychomycosis
Official title: Prospective, " Evaluator Blinded " Clinical Investigation to Evaluate the Effectiveness and Safety of Nailner Brush 2-in-1 in the Treatment of Onychomycosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Onychomycosis
Lead sponsor: Karo Pharma AB
Sponsor class: INDUSTRY
First posted: 2022-09-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Topical application of Nailner brush 2in1 (medical device) for the treatment of toenail onychomycosis
Primary purpose: TREATMENT

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.


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...).

Primary outcomes:
measure: To 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
timeFrame: Day 180
Secondary outcomes:
measure: To 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 1 and 3 months of treatment compared to baseline
timeFrame: Day 30, Day 90
measure: To evaluate the effectiveness of Nailner Brush 2-in-1 in the treatment of onychomycosis based on the microbiological cure (KOH staining)
timeFrame: Day 90, Day 180
measure: To evaluate the effectiveness of Nailner Brush 2-in-1 in the nail appearance
timeFrame: Day 30, Day 90, Day180
measure: To evaluate the effectiveness of Nailner Brush 2-in-1 in the improvement of the quality of life (QoL) of the patients.
timeFrame: Day 7, Day 30, Day 90, Day 180
measure: To evaluate the patient's opinion of Nailner Brush 2-in-1 effectiveness, tolerance, and acceptability.
timeFrame: Day 30, Day 90, Day 180
measure: To evaluate the safety of of Nailner Brush 2-in-1
timeFrame: Day 180
Other outcomes:
Locations:
city: Ben Arous
country: Tunisia
facility: Private practice
city: Tunis
country: Tunisia
facility: Private Practice
Study officials:
affiliation: Dermascan
name: Pr. Nejib DOSS, MD
role: PRINCIPAL_INVESTIGATOR
References: