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

Phase 4

Completed

• Conditions: Foot Dermatoses
• Interventions: Drug: Loceryl Nail Lacquer; Drug: Urea Ointment; Drug: Bifonazole Cream

• Registration Number: NCT02705664
• Lead Sponsor: Galderma R&D

Brief 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)

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-03-07
• Study First Submitted QC: 2016-03-09
• Study First Posted: 2016-03-10
• Status Verified: 2016-09
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Subjects with clinically Distal and Lateral Subungual Onychomycosis (DLSO) due to dermatophytes and/or yeast (including Candida) on at least one great toenail of each foot at screening visit,
• Subjects with less than 50% of the toenail surface area from the Distal edge with disease involvement and without matrix involvement, no dermatophytoma, streaks (spikes) or subungual hyperkeratosis > 2mm,
• Subjects should have the same number of affected toenails on both feet or no more than one additional affected toenail on one of the feet,
• Subjects with positive mycological results (direct microscopy and culture) of the most affected toenail (or great toenail) for dermatophytes or yeast (including Candida) at Baseline

Exclusion Criteria

• Subjects with matrix involvement on the great toenails,
• Subjects with a surgical, medical condition or clinically important abnormal physical findings which might interfere with the interpretation of the objectives of the study
• Post-traumatic toenail, lichen planus, eczema, psoriasis, or other abnormalities of the nail unit, which could affect/influence the subject's compliance with the investigational products or mask the effects of treatment (cure),
• Known immunodeficiency, radiation therapy, immune suppressive drugs,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Urea Ointment + Bifonazole Cream	Bifonazole Cream	On the opposite foot: 1. Urea 40% ointment to be applied once a day under occlusion for 2-3 weeks depending on the achievement of optimal diseased toenail plates removal) 2. Bifonazole 1% cream to be applied for 4 weeks on affected toenails (after the maximum 3-week treatment period with Urea ointment)
Loceryl NL	Loceryl Nail Lacquer	Amorolfine hydrochloride NL 5% to be applied once weekly for 7 weeks on all affected toenails of one foot
Urea Ointment + Bifonazole Cream	Urea Ointment	On the opposite foot: 1. Urea 40% ointment to be applied once a day under occlusion for 2-3 weeks depending on the achievement of optimal diseased toenail plates removal) 2. Bifonazole 1% cream to be applied for 4 weeks on affected toenails (after the maximum 3-week treatment period with Urea ointment)

Primary Outcome Measures

Name	Time	Method
% adherent subjects with applications	Week 7	Percent of subjects having applied both study treatments as instructed (once a week for Loceryl NL, once a day for urea and once a day for Bifonazole)
% Subjects satisfied to very satisfied with each study treatment at week 7	Week 7	Percent of subjects satisfied to very satisfied with each study treatment at week 7
% adherent subjects with nail preparation	Week 7	Percent of subjects having prepared affected toenails as instructed for each product before applications: * For Loceryl: File down the affected toenails as required and clean toenails surface with the cleansing swab; * For Urea: Soak toenails in warm water and remove soften infected toenails plates; * For Bifonazole: Clean and dry thoroughly affected toenails

Trial Locations

Locations (1)

Principal Investigator; 🇮🇸 Reykjavik, Iceland