Trials Sponsors Conditions Drugs Pricing

Conditions

Foot Dermatoses

Keywords

Onychomycosis

Outcome Measures

Primary Outcomes (1)

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)
Week 12

Secondary Outcomes (1)

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

Study Arms (2)

Loceryl NL

EXPERIMENTAL

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

Drug: Loceryl NL

Ciclopirox NL

ACTIVE COMPARATOR

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

Drug: Ciclopirox NL

Interventions

Loceryl NLDrug

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

Also known as: Loceryl Nail Lacquer

Loceryl NL

Ciclopirox NLDrug

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

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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,

Sponsors & Collaborators

Galderma R&D
Industrylead

Study Sites (1)

Tübingen, Germany

MeSH Terms

Conditions

Foot DermatosesOnychomycosis

Condition Hierarchy (Ancestors)

Foot DiseasesSkin DiseasesSkin and Connective Tissue DiseasesTineaDermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousNail Diseases

Results Point of Contact

Title: Farzaneh SIDOU Clinical Project Manager
Organization: Galderma

Study Officials

Prof. Schaller
Universitäts-Hautklinik
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: Yes

Enrollment

20 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 20, 2015

First Posted

February 11, 2016

Study Start

September 2015

Date type not reported

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Loceryl NL

Ciclopirox NL

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Loceryl NL

Ciclopirox NL

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations