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

Galderma logo

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

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems