Back to resultsEffectiveness and Safety of Nailner Brush 2in1 in Onychomycosis
Primary Purpose
Onychomycosis
Status
Completed
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
topical treatment
Sponsored by
About this trial
This is an interventional treatment trial for Onychomycosis
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…).
Sites / Locations
- Private practice
- Private Practice
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nailner 2 in 1
Arm 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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
To evaluate the effectiveness of Nailner Brush 2-in-1 in the treatment of onychomycosis based on the microbiological cure (KOH staining)
Percentage of patients with positive KOH staining at baseline and 3 and 6 months after treatment.
To evaluate the effectiveness of Nailner Brush 2-in-1 in the nail appearance
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.
To evaluate the effectiveness of Nailner Brush 2-in-1 in the improvement of the quality of life (QoL) of the patients.
Percentage of patient with an improvement of their quality of life (QoL) by analysis of NailQoL p
To evaluate the patient's opinion of Nailner Brush 2-in-1 effectiveness, tolerance, and acceptability.
Analysis of the answers to the patient questionnaire regarding effectiveness, tolerance, and acceptability of the investigational device 1, 3 and 6 months after treatment
To evaluate the safety of of Nailner Brush 2-in-1
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05560841
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
July 28, 2022 (Actual)
Primary Completion Date
January 12, 2023 (Actual)
Study Completion Date
April 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Karo Pharma AB
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Topical application of Nailner brush 2in1 (medical device) for the treatment of toenail onychomycosis
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nailner 2 in 1
Arm Type
Experimental
Arm 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
Intervention Type
Device
Intervention Name(s)
topical treatment
Intervention Description
Topical application of Nailner brush 2in1 for toenail onychomycosis
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Day 180
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Day 30, Day 90
Title
To evaluate the effectiveness of Nailner Brush 2-in-1 in the treatment of onychomycosis based on the microbiological cure (KOH staining)
Description
Percentage of patients with positive KOH staining at baseline and 3 and 6 months after treatment.
Time Frame
Day 90, Day 180
Title
To evaluate the effectiveness of Nailner Brush 2-in-1 in the nail appearance
Description
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.
Time Frame
Day 30, Day 90, Day180
Title
To evaluate the effectiveness of Nailner Brush 2-in-1 in the improvement of the quality of life (QoL) of the patients.
Description
Percentage of patient with an improvement of their quality of life (QoL) by analysis of NailQoL p
Time Frame
Day 7, Day 30, Day 90, Day 180
Title
To evaluate the patient's opinion of Nailner Brush 2-in-1 effectiveness, tolerance, and acceptability.
Description
Analysis of the answers to the patient questionnaire regarding effectiveness, tolerance, and acceptability of the investigational device 1, 3 and 6 months after treatment
Time Frame
Day 30, Day 90, Day 180
Title
To evaluate the safety of of Nailner Brush 2-in-1
Description
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
Time Frame
Day 180
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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…).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pr. Nejib DOSS, MD
Organizational Affiliation
Dermascan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Private practice
City
Ben Arous
Country
Tunisia
Facility Name
Private Practice
City
Tunis
Country
Tunisia
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness and Safety of Nailner Brush 2in1 in Onychomycosis
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