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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-01-31

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.

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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).

Conditions

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Foot Dermatoses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Only 12 first weeks of treatment with Loceryl NL and/or Loceryl alone were investigator masked and randomized.

15 months of treatment with Loceryl NL alone had an open study design

Study Groups

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Investigator blinded Loceryl NL+ Cosmetic varnish

Loceryl NL+ Cosmetic varnish once/week for 12 weeks on right or left foot toenails

Group Type EXPERIMENTAL

Loceryl NL + Cosmetic varnish

Intervention Type DRUG

Loceryl NL + Cosmetic varnish once/week for 12 weeks

Loceryl NL 15 months

Intervention Type DRUG

Loceryl once/week for additional 15 months

Investigator blinded Loceryl NL alone

Loceryl NL once/week for 12 weeks on right or left foot toenails

Group Type EXPERIMENTAL

Loceryl NL 12 weeks

Intervention Type DRUG

Loceryl NL once/week for 12 weeks

Loceryl NL 15 months

Intervention Type DRUG

Loceryl once/week for additional 15 months

Interventions

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Loceryl NL + Cosmetic varnish

Loceryl NL + Cosmetic varnish once/week for 12 weeks

Intervention Type DRUG

Loceryl NL 12 weeks

Loceryl NL once/week for 12 weeks

Intervention Type DRUG

Loceryl NL 15 months

Loceryl once/week for additional 15 months

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No