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The goal of this clinical investigation is to evaluate the efficacy of the tested products in medium to moderate onychomycosis after 112 days of treatments.
The main question it aims to answer is the effectiveness of the use of a combination of two investigational devices (Sérum PURIFIANT + Sérum BOOSTER) on the percentage of healthy nail surface after 112 days of treatment.
Participants will apply one or two devices on the affected toenail during the study.
For this investigation, 44 patients (22 patients per group) presenting at least one infected toenail will be included to reach this objective.
Onychomycosis is a fungal infection of the nail apparatus that causes discoloration, thickening, and separation from the nail bed.
It is primarily caused by dermatophytes, which are infectious fungi that feed on the keratin present in the skin, hair and nails. Onychomycosis has several clinical presentations, including distal and lateral subungual onychomycosis which is the most common form, proximal subungual onychomycosis, superficial white onychomycosis, and total dystrophic onychomycosis.
Onychomycosis affects toenails more often than fingernails because of their slower growth, reduced blood supply, and frequent confinement in dark, moist environments. (1) The severity of onychomycosis can be described as mild, moderate, or severe. Published studies will assign a label of mild-moderate disease if less than approximately 60% of the nail is showing symptoms.
Onychomycosis is the most common nail infection worldwide occurring in 10% of the general population but is more common in older adults. Despite treatment, the recurrence rate of onychomycosis is 10% to 50% as a result of reinfection or lack of mycotic cure.
Topical drugs for onychomycosis generally come in the form of lacquers or solutions directly applied to the surface of the nail.
The principal aim of this study is to evaluate the efficacy of the tested products in medium to moderate onychomycosis after 112 days of treatments. For this study, 44 patients (22 patients per group) presenting at least one infected toenail will be included to reach this objective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 : Sérum Mycose des ongles PURIFIANT | Experimental | Participant will apply Sérum PURIFIANT on the affected toenail, twice daily during the 112 days of the study. |
|
| Group 2 : Sérum Mycose des onglesPURIANT associated with Sérum Mycose des ongles BOOSTER | Experimental | Participant will apply Sérum PURIFIANT on the affected toenail, twice daily during the 112 days of the study. They will also apply Sérum BOOSTER, twice weekly before the Sérum PURIFIANT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sérum PURIFIANT | Device | Application of Sérum PURIFIANT only, twice daily during 112 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of healthy surface | The effect of the products on percentage of healthy surface will be evaluated at D112 by the mean variation from baseline in the group using a combination of two devices (Sérum PURIFIANT + Sérum BOOSTER). Evaluation is done in blind by digital analysis of photographs of the infected toenail. | Day 0, Day 112 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of healthy surface in group 1 | The effect of the product on percentage of healthy surface will be evaluated at D112 by the mean variation from baseline in the group using only one device (Sérum PURIFIANT). | Day 0, Day 112 |
| Percentage of healthy surface comparison |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aslham DOARIKA | Insight Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Insight Research | Quatres Bornes | Mauritius |
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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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| Sérum PURIFIANT in association Sérum BOOSTER | Device | Application of Sérum PURIFIANT twice daily during 112 days AND Application of Sérum BOOSTER before the Serum PURIFIANT, twice weekly |
|
The effect of the products on percentage of healthy surface will be evaluated at D112 by comparing mean variation from baseline between the two groups. |
| Day 0, Day 112 |
| Onychomycosis | The effect of the product on onychomycosis improvement will be evaluated at D0 and 112 days after treatment, on a scale from 0 normal to 3 severe. The effect of the products on clinical parameters will be evaluated by comparing mean variation from D0 within group and between the two groups. | Day 0, Day 112 |
| Onycholysis | The effect of the product on onycholysis improvement will be evaluated at D0 and 112 days after treatment, on a scale from 0 normal to 3 severe The effect of the products on clinical parameters will be evaluated by comparing mean variation from D0 within group and between the two groups. | Day 0, Day 112 |
| Nail microcacking | The effect of the product on nail microcacking improvement will be evaluated at D0 and 112 days after treatment. Number of nail microcracking will be collected. The effect of the products on clinical parameters will be evaluated by comparing mean variation from D0 within group and between the two groups. | Day 0, Day 112 |
| Nail opacity | The effect of the product on nail opacity improvement will be evaluated at D0 and 112 days after treatment, on a scale from 0 transparent to 4 Very opaque The effect of the products on clinical parameters will be evaluated by comparing mean variation from D0 within group and between the two groups. | Day 0, Day 112 |
| KOH staining | Percentage of patients with positive KOH staining at the screening visit and 112 days after treatment in each group and compared between the two groups. | Day 0, Day 112 |
| QoL | Percentage of patient with an improvement of their quality of life (QoL) by analysis of NailQoL patient answers at D0 and 112 days after treatment in each group and compared between the two groups. | Day 0, Day 112 |
| Patient questionnaire | Analysis of the answers to the patient questionnaire regarding effectiveness, tolerance, and acceptability of the investigational devices 112 days after treatment in each group. Answer will be on a scale from Totally agree to totally disagree | Day 0, Day 112 |
| Tolerance | Products tolerance will be assessed by the investigator and the patient at D112 on a 4 points scale from verry bad tolerance to very good tolerance | Day 0, Day 112 |
| Adverse event | Products 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. | Screening visit, Day 0, Day 112 |
| D007239 |
| Infections |
| D012874 | Skin Diseases, Infectious |
| D009260 | Nail Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |