Antifungal Activity of Loceryl Nail Lacquer in Combination With a Cosmetic Varnish

Study Overview
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Brief Summary
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The main objective is to compare efficacy, in terms of antifungal activity of Loceryl Nail Lacquer associated with a Cosmetic Varnish and Loceryl Nail Lacquer alone, in the treatment of mild to moderate toenail Distal Subungual Onychomycosis. The second objective of this study will be photographic follow-up of clinical improvement and cure after the initial treatment period of 12 weeks, for 15 additional months.

Detailed Description
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Study center: A total of 50 subjects were to be included in 1 site in Iceland. Methodology: Group Loceryl Nail Lacquer+ Cosmetic Varnish: Loceryl Nail Lacquer to be applied once weekly for 12 weeks on all affected toenails, Cosmetic varnish to be applied once weekly for 12 weeks on all affected toenails and/or all toenails. Group Loceryl Nail Lacquer alone: - Loceryl Nail Lacquer to be applied once weekly for 12 weeks on all affected toenails. All eligible subejct with no clinical sign of clinical aggravation of Onychomycosis at week 12, could continue to apply Loceryl Nail Lacquer alone, once a week for 15 additional months (or less in case of complete cure).

Official Title
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Determination of Antifungal Activity of Loceryl Nail Lacquer 5% When Used Concomitantly With a Cosmetic Nail Varnish Compared to a Loceryl Nail Lacquer (NL) 5% Alone in Treatment of Toenail Distal Subungual Onychomycosis

Conditions
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Foot Dermatoses

Intervention / Treatment
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* Drug: Loceryl NL + Cosmetic varnish
* Drug: Loceryl NL 12 weeks
* Drug: Loceryl NL 15 months


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with a mild to moderate Distal Subungual Onychomycosis (DSO) on at least 1 great toenail chosen as a Target nail Subjects must have maximum of 50% of nail distal edge involved Subjects with positive mycological results (direct microscopy and culture) of the Target nail for dermatophytes or Yeast (including Candida) at Screening Exclusion Criteria: Subjects with clinically important abnormal physical findings at the Screening/Baseline visit Subjects with Lichen planus, eczema, psoriasis, or other abnormalities of the nail unit Subjects with known immunodeficiencies, 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigator blinded Loceryl NL+ Cosmetic varnish<br>Loceryl NL+ Cosmetic varnish once/week for 12 weeks on right or left foot toenails | Drug: Loceryl NL + Cosmetic varnish<br>* Loceryl NL + Cosmetic varnish once/week for 12 weeks<br>Drug: Loceryl NL 15 months<br>* Loceryl once/week for additional 15 months<br>|
| Experimental: Investigator blinded Loceryl NL alone<br>Loceryl NL once/week for 12 weeks on right or left foot toenails | Drug: Loceryl NL 12 weeks<br>* Loceryl NL once/week for 12 weeks<br>Drug: Loceryl NL 15 months<br>* Loceryl once/week for additional 15 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of Antifungal Activity of Loceryl Nail Lacquer | Measurement of diameter of zones of inhibition (mm) produced by residual drug in toenails | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of Dermatophytes in Nail Samples Culture |  | Week 12 | 

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