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

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

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).

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