Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus Ciclopirox Nail Lacquer

Study Overview
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Brief Summary
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The main objective of this study is to compare subject's compliance and satisfaction for two modes of treatment of toenails infection (Onychomycosis) with Loceryl Nail Lacquer (Loceryl NL) and Ciclopirox Nail Lacquer (Ciclopirox NL).

Detailed Description
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A total of 20 subjects are to be included in 1 site in Germany. Methodology: Subjects will receive the following treatments on the right or left toenails: Loceryl Nail Lacquer to be applied once weekly for 12 weeks on all affected toenails of one foot. Ciclopirox Nail Lacquer to be applied once daily for 12 weeks on all affected toenails of the opposite foot.

Official Title
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Subject Adherence and Satisfaction for Treatment of Onychomycosis With Loceryl Nail Lacquer 5% Versus Ciclopirox Nail Lacquer

Conditions
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Foot Dermatoses

Intervention / Treatment
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* Drug: Loceryl NL
* Drug: Ciclopirox NL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject with clinically Distal and Lateral Subungual Onychomycosis (DLSO) due to dermatophytes and/or yeast (including Candida) on at least one toenail of each foot at screening visit, Subject with less than 80% of the nail surface area with disease involvement and without matrix involvement, no dermatophytoma, streaks (spikes) or subungual hyperkeratosis > 2mm, Subjects with positive mycological results (direct microscopy and culture) for dermatophytes and/or yeasts (including Candida) at baseline, Subjects with same number of affected toenails on both feet or no more than one additional affected toenail on one of the feet, Exclusion Criteria: Subject with a surgical, medical condition or clinically important abnormal physical findings, which, in the judgement of the investigator, might interfere with interpretation of the objectives of the study (i.e. lack of autonomy), Subjects with post-traumatic nail, lichen planus, eczema, psoriasis, or other abnormalities of the nail unit, which could affect/influence the subject's compliance of the investigational products, or mask the effects of treatment (cure), Subjects with known immunodeficiency, radiation therapy, immune suppressive drugs.

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
Interventional Model Description: Intra-individual study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Loceryl NL<br>Amorolfine hydrochloride NL 5% to be applied once weekly for 12 weeks on all affected toenails of one foot | Drug: Loceryl NL<br>* Topical over the entire toenail plate of all affected toenails, once weekly in the evening (at bed time) after filing down the affected toenails.<br>* Other names: Loceryl Nail Lacquer;|
| Active Comparator: Ciclopirox NL<br>Ciclopirox NL 8% to be applied once daily for 12 weeks on all affected toenails of the opposite foot | Drug: Ciclopirox NL<br>* Topical over the entire toenail plate of all affected toenails and surrounding skin, once daily in the evening (at bed time) after removing the free toenail edge and diseased toenails if needed<br>* Other names: Ciclopirox Nail Lacquer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of in Label Adherent Subjects | Percent of subjects having applied both treatments as instructed per labeling (once a week for Loceryl NL and once a day for Ciclopirox after 2 weeks) | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Subjects Satisfied to Very Satisfied With Each Study Treatment at Week 12 | Percent of subjects satisfied to very satisfied with both treatments (Loceryl nail lacquer and/or Ciclopirox nail lacquer) at week 12 | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Onychomycosis