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

Phase 4

Completed

• Conditions: Foot Dermatoses
• Interventions: Drug: Loceryl NL; Drug: Ciclopirox NL

• Registration Number: NCT02679911
• Lead Sponsor: Galderma R&D

Brief Summary

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).

Detailed 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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-11-20
• Study First Submitted QC: 2016-02-08
• Study First Posted: 2016-02-11
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2018-02
• Results First Submitted: 2018-02-15
• Results First Submitted QC: 2018-02-15
• Results First Posted: 2018-10-03
• Last Update Submitted: 2021-02-24
• Last Update Posted: 2021-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Loceryl NL	Loceryl NL	Amorolfine hydrochloride NL 5% to be applied once weekly for 12 weeks on all affected toenails of one foot
Ciclopirox NL	Ciclopirox NL	Ciclopirox NL 8% to be applied once daily for 12 weeks on all affected toenails of the opposite foot

Primary Outcome Measures

Name	Time	Method
Percent of "in Label" Adherent Subjects	Week 12	Percent of subjects having applied both treatments as instructed per labeling (once a week for Loceryl NL and once a day for Ciclopirox after 2 weeks)

Secondary Outcome Measures

Name	Time	Method
Percent of Subjects Satisfied to Very Satisfied With Each Study Treatment at Week 12	Week 12	Percent of subjects satisfied to very satisfied with both treatments (Loceryl nail lacquer and/or Ciclopirox nail lacquer) at week 12