Onychomycosis
Conditions
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.
Interventions
DEVICEtopical treatment
Topical application of Nailner brush 2in1 for toenail onychomycosis
Sponsors
Karo Pharma AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Topical application of Nailner brush 2in1 (medical device) for the treatment of toenail onychomycosis
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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…).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 nail appearance | 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. |
| 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 | Percentage of patients with positive KOH staining at baseline and 3 and 6 months after treatment. |
| To evaluate the patient's opinion of Nailner Brush 2-in-1 effectiveness, tolerance, and acceptability. | 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 |
| To evaluate the safety of of Nailner Brush 2-in-1 | 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 |
| 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 | Percentage of patient with an improvement of their quality of life (QoL) by analysis of NailQoL p |
Countries
Tunisia
Outcome results
None listed