Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus a Two-course Treatment With Urea 40% Ointment and Bifonazole Cream 1%
Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus a Two-course Treatment With Urea 40% Ointment and Bifonazole Cream 1%
The main objective of this study is to compare subject adherence and satisfaction for two
 modes of treatment toenails infection (Onychomycosis) with Loceryl Nail Lacquer (Loceryl NL)
 and a Fungal Nail Treatment Set containing Urea 40% ointment (Urea) and Bifonazole cream 1%
 (Bifonazole).
A total of 20 subjects are to be included in 1 site in Iceland

 Methodology:

 Subjects will receive following treatments on the right or left toenails:

 -  Loceryl Nail Lacquer (Loceryl NL) to be applied once weekly for 7 weeks on all affected
 toenails of one foot (including great toenail)

 -  Fungal Nail Treatment Set to be used on all affected toenails (including great toenail)
 of the opposite foot in two phases:

 -  Phase I: Urea ointment (Urea) to be applied once a day under occlusion for 2-3
 weeks depending on the achievement of optimal diseased toenail plates removal

 -  Phase II: Bifonazole cream to (Bifonazole) be applied for 4 weeks on affected
 toenails (after the maximum 3-week treatment period with Urea ointment)
Inclusion Criteria:

 -  Subjects with clinically Distal and Lateral Subungual Onychomycosis (DLSO) due to
 dermatophytes and/or yeast (including Candida) on at least one great toenail of each
 foot at screening visit,

 -  Subjects with less than 50% of the toenail surface area from the Distal edge with
 disease involvement and without matrix involvement, no dermatophytoma, streaks
 (spikes) or subungual hyperkeratosis > 2mm,

 -  Subjects should have the same number of affected toenails on both feet or no more than
 one additional affected toenail on one of the feet,

 -  Subjects with positive mycological results (direct microscopy and culture) of the most
 affected toenail (or great toenail) for dermatophytes or yeast (including Candida) at
 Baseline

 Exclusion Criteria:

 -  Subjects with matrix involvement on the great toenails,

 -  Subjects with a surgical, medical condition or clinically important abnormal physical
 findings which might interfere with the interpretation of the objectives of the study

 -  Post-traumatic toenail, lichen planus, eczema, psoriasis, or other abnormalities of
 the nail unit, which could affect/influence the subject's compliance with the
 investigational products or mask the effects of treatment (cure),

 -  Known immunodeficiency, radiation therapy, immune suppressive drugs,