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

Foot Dermatoses Clinical Trial

Official title: 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

Status Completed

Clinical Trial 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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Foot Dermatoses
• Skin Diseases

• NCT number: NCT02321098
• Study type: Interventional
• Source: Galderma R&D
• Status: Completed
• Phase: Phase 4
• Start date: February 2014
• Completion date: January 2016