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

NCT02705664 | Completed Phase 4

• 1 other identifier: RD.03.SPR.105078
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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).

Conditions

Foot Dermatoses

Keywords

Onychomycosis

Outcome Measures

Primary Outcomes (3)

• % adherent subjects with applications

  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)

  Week 7

• % adherent subjects with nail preparation

  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

  Week 7

• % Subjects satisfied to very satisfied with each study treatment at week 7

  Percent of subjects satisfied to very satisfied with each study treatment at week 7

  Week 7

Study Arms (2)

Loceryl NL

EXPERIMENTAL

Amorolfine hydrochloride NL 5% to be applied once weekly for 7 weeks on all affected toenails of one foot

Drug: Loceryl Nail Lacquer

Urea Ointment + Bifonazole Cream

ACTIVE COMPARATOR

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)

Drug: Urea Ointment; Drug: Bifonazole Cream

Interventions

Loceryl Nail Lacquer DRUG

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

Also known as: Loceryl NL

Loceryl NL

Urea Ointment DRUG

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

Also known as: Urea

Urea Ointment + Bifonazole Cream

Bifonazole Cream DRUG

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

Also known as: Bifonazole

Urea Ointment + Bifonazole Cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

Principal Investigator

Reykjavik, Iceland

Location

MeSH Terms

Conditions

Foot Dermatoses; Onychomycosis

Interventions

Urea; bifonazole

Condition Hierarchy (Ancestors)

Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals

Study Officials

• Dr Sigurgeirsson

  Cutis Ehf (Dermatology Center)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2016
• First Posted: March 10, 2016
• Study Start: January 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: February 17, 2021

Record last verified: 2016-09

Locations

IC (1)