Effectiveness and Safety of Nailner Brush 2in1 in Onychomycosis

NCT05560841 | Completed

• 1 other identifier: 21E4142
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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

  Mean variation from baseline of the percentage of healthy surface after 6 months of treatment. Evaluation is done in blind by digital analysis of photographs of the infected toenail.

  Day 180

Secondary Outcomes (6)

• 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

  Day 30, Day 90

• To evaluate the effectiveness of Nailner Brush 2-in-1 in the treatment of onychomycosis based on the microbiological cure (KOH staining)

  Day 90, Day 180

• To evaluate the effectiveness of Nailner Brush 2-in-1 in the nail appearance

  Day 30, Day 90, Day180

• To evaluate the effectiveness of Nailner Brush 2-in-1 in the improvement of the quality of life (QoL) of the patients.

  Day 7, Day 30, Day 90, Day 180

• To evaluate the patient's opinion of Nailner Brush 2-in-1 effectiveness, tolerance, and acceptability.

  Day 30, Day 90, Day 180

Study Arms (1)

Nailner 2 in 1

EXPERIMENTAL

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

Device: topical treatment

Interventions

topical treatment DEVICE

Topical application of Nailner brush 2in1 for toenail onychomycosis

Nailner 2 in 1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant, breastfeeding woman or woman planning a pregnancy during the study;
• 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…).

Sponsors & Collaborators

• Karo Pharma AB: lead

Study Sites (2)

Private practice

Ben Arous, Tunisia

Location

Private Practice

Tunis, Tunisia

Location

MeSH Terms

Conditions

Onychomycosis

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Pr. Nejib DOSS, MD

  Dermascan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Topical application of Nailner brush 2in1 (medical device) for the treatment of toenail onychomycosis

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 29, 2022
• Study Start: July 28, 2022
• Primary Completion: January 12, 2023
• Study Completion: April 10, 2023
• Last Updated: October 4, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)