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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| topical treatment | Device | Topical application of Nailner brush 2in1 for toenail onychomycosis |
|
| 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 | 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 |
| 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pr. Nejib DOSS, MD | Dermascan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private practice | Ben Arous | Tunisia | ||||
| Private Practice |
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| ID | Term |
|---|---|
| D014009 | Onychomycosis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Topical application of Nailner brush 2in1 (medical device) for the treatment of toenail onychomycosis
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| 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. | 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. | 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 | Day 7, Day 30, Day 90, Day 180 |
| 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 | 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 | Day 180 |
| Tunis |
| Tunisia |
| D007239 |
| Infections |
| D012874 | Skin Diseases, Infectious |
| D009260 | Nail Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |