NCT02321098

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Foot Dermatoses

Interventions

Type	Name	Description
DRUG	Loceryl NL + Cosmetic varnish	Loceryl NL + Cosmetic varnish once/week for 12 weeks
DRUG	Loceryl NL 12 weeks	Loceryl NL once/week for 12 weeks
DRUG	Loceryl NL 15 months	Loceryl once/week for additional 15 months

Timeline

• Start date: 2014-02-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2014-12-22
• Last updated: 2023-01-19
• Results posted: 2018-10-09

Locations

1 site across 1 country: Iceland