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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Topical application of Nailner brush 2in1 for toenail onychomycosis
Private practice
Ben Arous, Tunisia
Private Practice
Tunis, Tunisia
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.
Time frame: Day 180
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.
Time frame: 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)
Percentage of patients with positive KOH staining at baseline and 3 and 6 months after treatment.
Time frame: Day 90, Day 180
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.
Time frame: 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.
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
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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
Time frame: Day 30, Day 90, Day 180
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
Time frame: Day 180