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

Primary Purpose

Foot Dermatoses

Status

Completed

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Loceryl NL

Ciclopirox NL

About this trial

This is an interventional treatment trial for Foot Dermatoses focused on measuring Onychomycosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Loceryl NL

Ciclopirox NL

Arm Description

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

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

Outcomes

Primary Outcome Measures

Percent of "in Label" Adherent Subjects

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

Percent of Subjects Satisfied to Very Satisfied With Each Study Treatment at Week 12

Percent of subjects satisfied to very satisfied with both treatments (Loceryl nail lacquer and/or Ciclopirox nail lacquer) at week 12

Full Information

NCT ID

NCT02679911

First Posted

November 20, 2015

Last Updated

February 24, 2021

Sponsor

Galderma R&D

1. Study Identification

Unique Protocol Identification Number

NCT02679911

Brief Title

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

Acronym

LOOP

Official Title

Subject Adherence and Satisfaction for Treatment of Onychomycosis With Loceryl Nail Lacquer 5% Versus Ciclopirox Nail Lacquer

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

September 2015 (undefined)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Galderma R&D

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Foot Dermatoses

Keywords

Onychomycosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Intra-individual study

Masking

Investigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Loceryl NL

Arm Type

Experimental

Arm Description

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

Arm Title

Ciclopirox NL

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Loceryl NL

Other Intervention Name(s)

Loceryl Nail Lacquer

Intervention Description

Topical over the entire toenail plate of all affected toenails, once weekly in the evening (at bed time) after filing down the affected toenails.

Intervention Type

Drug

Intervention Name(s)

Ciclopirox NL

Other Intervention Name(s)

Ciclopirox Nail Lacquer

Intervention Description

Topical over the entire toenail plate of all affected toenails and surrounding skin, once daily in the evening (at bed time) after removing the free toenail edge and diseased toenails if needed

Primary Outcome Measure Information:

Title

Percent of "in Label" Adherent Subjects

Description

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)

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

Percent of Subjects Satisfied to Very Satisfied With Each Study Treatment at Week 12

Description

Percent of subjects satisfied to very satisfied with both treatments (Loceryl nail lacquer and/or Ciclopirox nail lacquer) at week 12

Time Frame

Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Prof. Schaller

Organizational Affiliation

Universitäts-Hautklinik

Official's Role

Principal Investigator

Facility Information:

City

Tübingen

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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