Conditions: Foot Dermatoses
Keywords: Onychomycosis antifungal
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 50
Healthy volunteers: no

Brief summary:
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:
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).

Arms:
arm 1: Loceryl NL+ Cosmetic varnish once/week for 12 weeks on right or left foot toenails arm 2: Loceryl NL once/week for 12 weeks on right or left foot toenails

Interventions: intervention 1: Loceryl NL + Cosmetic varnish intervention 2: Loceryl NL 12 weeks intervention 3: Loceryl NL 15 months
Intervention descriptions: intervention 1: Loceryl NL + Cosmetic varnish once/week for 12 weeks intervention 2: Loceryl NL once/week for 12 weeks intervention 3: Loceryl once/week for additional 15 months

Protocol document: