NCT02679911

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 11, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

October 3, 2018

Completed
Last Updated

March 22, 2021

Status Verified

February 1, 2018

Enrollment Period

9 months

First QC Date

November 20, 2015

Results QC Date

February 15, 2018

Last Update Submit

February 24, 2021

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

Also known as: Ciclopirox Nail Lacquer
Ciclopirox NL

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,
  • 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,

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tübingen, Germany

Location

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
farzaneh.sidou@galderma.com
0493957051

Study Officials

  • Prof. Schaller

    Universitäts-Hautklinik

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

November 20, 2015

First Posted

February 11, 2016

Study Start

September 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

March 22, 2021

Results First Posted

October 3, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)