Effectiveness and Safety of Nailner Brush 2in1 in Onychomycosis

October 3, 2023 updated by: Karo Pharma AB

Prospective, " Evaluator Blinded " Clinical Investigation to Evaluate the Effectiveness and Safety of Nailner Brush 2-in-1 in the Treatment of Onychomycosis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Tunisia
      • Ben Arous, Tunisia
        • Private practice
      • Tunis, Tunisia
        • Private practice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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…).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Device: topical treatment
Topical application of Nailner brush 2in1 for toenail onychomycosis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: Day 180
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: Day 30, Day 90
Mean variation from baseline of the percentage of healthy surface after 1 and 3 months of treatment. Evaluation is done in blind by digital analysis of photographs of the infected toenail.
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)
Time Frame: Day 90, Day 180
Percentage of patients with positive KOH staining at baseline and 3 and 6 months after treatment.
Day 90, Day 180
To evaluate the effectiveness of Nailner Brush 2-in-1 in the nail appearance
Time Frame: Day 30, Day 90, Day180
Mean variation from baseline of the onychomycosis evaluation ( onycholysis, nail dystrophy, nail discoloration and nail thickening) as assessed by the investigator in live at baseline and 1, 3 and 6 months after treatment.
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.
Time Frame: Day 7, Day 30, Day 90, Day 180
Percentage of patient with an improvement of their quality of life (QoL) by analysis of NailQoL p
Day 7, Day 30, Day 90, Day 180
To evaluate the patient's opinion of Nailner Brush 2-in-1 effectiveness, tolerance, and acceptability.
Time Frame: Day 30, Day 90, Day 180
Analysis of the answers to the patient questionnaire regarding effectiveness, tolerance, and acceptability of the investigational device 1, 3 and 6 months after treatment
Day 30, Day 90, Day 180
To evaluate the safety of of Nailner Brush 2-in-1
Time Frame: Day 180
Product safety will be assessed by collection of Adverse Events (Aes) throughout the study. AEs will be summarized and tabulated by severity, causality, action taken and outcome, using descriptive statistics
Day 180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karo Pharma AB

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pr. Nejib DOSS, MD, Dermascan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 28, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 12, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 10, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21E4142

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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