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

February 24, 2021 updated by: Galderma R&D

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Loceryl NL
Amorolfine hydrochloride NL 5% to be applied once weekly for 12 weeks on all affected toenails of one foot
Drug: Loceryl NL
Topical over the entire toenail plate of all affected toenails, once weekly in the evening (at bed time) after filing down the affected toenails.
Other Names:
  • Loceryl Nail Lacquer
Active Comparator: Ciclopirox NL
Ciclopirox NL 8% to be applied once daily for 12 weeks on all affected toenails of the opposite foot
Drug: Ciclopirox NL
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
Other Names:
  • Ciclopirox Nail Lacquer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of "in Label" Adherent Subjects
Time Frame: 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)
Week 12

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Investigators

  • Principal Investigator: Prof. Schaller, Universitäts-Hautklinik

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

November 20, 2015

First Submitted That Met QC Criteria

February 8, 2016

First Posted (Estimate)

February 11, 2016

Study Record Updates

Last Update Posted (Actual)

March 22, 2021

Last Update Submitted That Met QC Criteria

February 24, 2021

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD.03.SPR105082
  • 2015-001237-24 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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