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

Galderma

Status and phase: Completed; Phase 4

Conditions: Foot Dermatoses

Treatments: Drug: Loceryl Nail Lacquer; Drug: Bifonazole Cream; Drug: Urea Ointment

Study type: Interventional

Funder types: Industry

Identifiers

NCT02705664

RD.03.SPR.105078

Details and patient eligibility

About

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).

Full 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)

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

22 participants in 2 patient groups

Loceryl NL

Experimental group

Description:

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

Treatment:

Drug: Loceryl Nail Lacquer

Urea Ointment + Bifonazole Cream

Active Comparator group

Description:

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)

Treatment:

Drug: Urea Ointment

Drug: Bifonazole Cream