NCT02705664

Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus a Two-course Treatment With Urea 40% Ointment and Bifonazole Cream 1%

Subject Adherence and Satisfaction for Treatment of Onychomycosis With Loceryl Nail Lacquer 5% Versus a Fungal Nail Treatment Set Containing Urea 40% Ointment and Bifonazole Cream 1%

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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)

Conditions

• Foot Dermatoses

Interventions

Type	Name	Description
DRUG	Loceryl Nail Lacquer	Topical over entire toenail plates of affected toenails once weekly in the evening (at bed time) after having filled down affected toenails to gently remove as much as affected nails and having cleaned toenails surfaces with the provided cleansing swab
DRUG	Urea Ointment	Topical over the infected part of the toenails only once daily under occlusion in the evening (at bed time) after having soaked toenails in warm water and having removed the soften infected toenail plates and dried the toenails
DRUG	Bifonazole Cream	Topical, to be rubbed sparingly over the affected toenail skin (nail bed) once daily in the evening (at bed time) after having cleaned and dried thoroughly toenails

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2016-03-10
• Last updated: 2021-02-17

Locations

1 site across 1 country: Iceland