Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis

Study Overview
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Brief Summary
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This study evaluates the effect of the medical device Excilor® Forte in the treatment of toenail onychomycosis. Half of the participants will receive the tested product and the other half will receive a comparator (Amorolfin 5%). Patients will be followed during 6 months.

Official Title
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Clinical Evaluation of Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis.

Conditions
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Onychomycosis of Toenail

Intervention / Treatment
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* Device: Excilor Forte
* Drug: Loceryl 5%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject having given her/his informed, written consent. Subject cooperative and aware of the modalities of use and the necessity and duration of the controls so that perfect adhesion to the protocol can be expected. Subject being psychologically able to understand information and to give their/his/her consent. Age: more than 18 years. Subject with superficial onychomycosis on at least one great toenail or light to moderate disto-lateral onychomycosis (without matrix involvement and involvement <2/3 of the tablet). Subject with positive KOH staining. Subject having stopped any systemic antifungal treatment since at least 6 months before inclusion and/or any topical antifungal treatment since at least 3 months before inclusion. Female subjects of childbearing potential should use an accepted contraceptive regimen since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after study end. Exclusion Criteria: Subject considered by the Investigator likely to be non-compliant with the protocol. Patient enrolled in another clinical trial during the test period. · Woman being pregnant, nursing or planning a pregnancy during the course of this study. Subject having a known allergy to one of the constituents of the tested products. Patient suffering from serious or progressive diseases (to investigator's discretion) such as uncontrolled diabetes, peripheral circulatory disease, HIV, psoriasis, lichen planus, immunosuppressive pathology… Subject with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis…).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Excilor Forte<br> | Device: Excilor Forte<br>* 1 application per day during 6 months<br>|
| Active Comparator: Loceryl 5%<br> | Drug: Loceryl 5%<br>* 1 application per week during 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of the percentage of healthy surface after 30, 60, 120, and 180 days between both treatments, and versus baseline. Evaluation is done by digital analysis of photographs of the great, infected toenail | Subjects with a great toenail, affected by onychomycosis, were treated with the test medical device or reference product, respectively. After 180 days, blind assessment of the percentage of healthy surface (primary efficacy endpoint) of the great toenail was performed to evaluate changes from baseline between both treatment groups. Additionally, blind assessment of the percentage of healthy surface of the great toenail will be performed at all other visits (day 30, 60, and 120, respectively) to evaluate changes from baseline between both treatment groups | After 30, 60, 120 and 180 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of clinical efficacy by the investigator, assessing the following parameters: onychomycosis evolution, onycholysis, dystrophy, discoloration, and nail thickening, following treatment with test medical device versus reference product. | Onycholysis, nail distrophy, nail discoloration, and nail thickening was evaluated by a blinded investigator, using the following scores: 0 = none, 1 = very slight, 2 = slight, 3 = moderate, and 4 = severe. Onychomycosis evolution was scored as follows: 1 = failure (aggravation, increase total infected area), 2 = status quo, 3 = improvement (decrease of total infected area), 4 = success: disappearance of the total infected area. In order to compare changes in nail dystrophy, discoloration, and nail thickening between baseline and day 180, five categories were reduced to two categories (none to slight versus moderate to severe). The Mc Nemar test for paired data was used to test if there was a change in nail dystrophy, discoloration, and nail thickening between baseline and day 180. A chi-square test test was performed to compare changes between both treatments in onychomycosis evolution. Note: scores are used and for this reason, no units of measure can be assigned. | After 30, 60, 120 and 180 days of treatment | 
| Evaluation of microbiological efficacy of the product, using KOH staining and fungal culture on D0 and D180 versus reference product. | Patients with positive KOH staining were included in the study. In addition, a fungal culture was performed to identify the involved species. At day 180, a new KOH staining and fungal culture was performed to evaluate the impact of each treatment on both microbiological parameters. | At baseline (day 0) and after 180 days of treatment | 
| Evaluation of product tolerance at each visit during the trial, assessed by the investigator by clinical evaluation and subject interrogatory. | The investigator assigned a score from 0 (bad tolerance) to 3 (very good tolerance). | After 30, 60, 120 and 180 days of treatment | 
| Evaluation of the quality of life of the subjects using a validated questionnaire (NailQoL) before (baseline), after 60 and 180 days of treatment with test product, versus comparator. | A NailQol global score of 0 corresponds with a quality of life never altered by onychomycosis, whereas a score of 100 corresponds to a quality of life that is always affected by onychomycosis. | After 60 and 180 days of treatment | 
| Subject evaluation using an evaluation questionnaire, performed at each visit. | A questionnaire was included to evaluate product usability and functionality of Excilor Forte. The questionnaire was completed at each evaluation point (day 30, 60, 120, and 180, respectively). General questions were asked regarding the cosmetic effect (e.g. smoothening, brightening effect, conventional packaging..), overall satisfaction (e.g. smell, fits daily routine ...), product application (e.g. ease of application, drying time, stress-resistance, combination with top coat...), purchase intent and tolerance were asked. Subjects needed to score as follows: strongly agree, agree, neutral, disagree, strongly disagree, not concerned. Data were summarized in frequencies. | After 30, 60, 120 and 180 days of treatment |