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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
Loceryl NL + Cosmetic varnish once/week for 12 weeks
Loceryl NL once/week for 12 weeks
Loceryl once/week for additional 15 months
Principal Investigator
Reykjavik, Iceland
Measurement of Antifungal Activity of Loceryl Nail Lacquer
Measurement of diameter of zones of inhibition (mm) produced by residual drug in toenails
Time frame: Week 12
Absence of Dermatophytes in Nail Samples Culture
Time frame: Week 12
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