Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus Ciclopirox Nail Lacquer (LOOP)

Galderma

Status and phase: Completed; Phase 4

Conditions: Foot Dermatoses

Treatments: Drug: Loceryl NL; Drug: Ciclopirox NL

Study type: Interventional

Funder types: Industry

Identifiers

NCT02679911

2015-001237-24 (EudraCT Number)

RD.03.SPR105082

Details and patient eligibility

About

The main objective of this study is to compare subject's compliance and satisfaction for two modes of treatment of toenails infection (Onychomycosis) with Loceryl Nail Lacquer (Loceryl NL) and Ciclopirox Nail Lacquer (Ciclopirox NL).

Full description

A total of 20 subjects are to be included in 1 site in Germany.

Methodology:

Subjects will receive the following treatments on the right or left toenails:

• Loceryl Nail Lacquer to be applied once weekly for 12 weeks on all affected toenails of one foot.
• Ciclopirox Nail Lacquer to be applied once daily for 12 weeks on all affected toenails of the opposite foot.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject with clinically Distal and Lateral Subungual Onychomycosis (DLSO) due to dermatophytes and/or yeast (including Candida) on at least one toenail of each foot at screening visit,
• Subject with less than 80% of the nail surface area with disease involvement and without matrix involvement, no dermatophytoma, streaks (spikes) or subungual hyperkeratosis > 2mm,
• Subjects with positive mycological results (direct microscopy and culture) for dermatophytes and/or yeasts (including Candida) at baseline,
• Subjects with same number of affected toenails on both feet or no more than one additional affected toenail on one of the feet,

Exclusion criteria

• Subject with a surgical, medical condition or clinically important abnormal physical findings, which, in the judgement of the investigator, might interfere with interpretation of the objectives of the study (i.e. lack of autonomy),
• Subjects with post-traumatic nail, lichen planus, eczema, psoriasis, or other abnormalities of the nail unit, which could affect/influence the subject's compliance of the investigational products, or mask the effects of treatment (cure),
• Subjects with known immunodeficiency, radiation therapy, immune suppressive drugs.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Loceryl NL

Experimental group

Description:

Amorolfine hydrochloride NL 5% to be applied once weekly for 12 weeks on all affected toenails of one foot

Treatment:

Drug: Loceryl NL

Ciclopirox NL

Active Comparator group

Description:

Ciclopirox NL 8% to be applied once daily for 12 weeks on all affected toenails of the opposite foot

Treatment:

Drug: Ciclopirox NL

Sponsor of this trial

Lead Sponsor

Galderma