NCT00459537

Brief Summary

This study will evaluate the efficacy, safety and tolerability of topical 10% terbinafine hydrogen chloride applied daily versus 5% amorolfine nail lacquer applied twice a week in patients with mild to moderate toenail onychomycosis, for a total treatment duration of 48 weeks.

Trial Health

98
On Track

Trial Health Score

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

Enrollment
1,029

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2007

Geographic Reach
10 countries

10 active sites

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

March 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 10, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 12, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

April 20, 2011

Completed
Last Updated

May 6, 2011

Status Verified

May 1, 2011

Enrollment Period

1.8 years

First QC Date

April 10, 2007

Results QC Date

January 19, 2011

Last Update Submit

May 3, 2011

Conditions

Onychomycosis

Keywords

Toenail fungusOnychomycosisNail fungusToenail fungal infectionTinea unguiumDermatophytesFoot dermatoses

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants With Complete Cure at the End of Study After Treating Participants for 48 Weeks

    Complete cure is defined as negative potassium hydroxide (KOH) microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.

    Week 52

  • Percentage of Participants With Complete Cure at the End of Study After Treating Participants for 48 Weeks.

    Complete cure is defined as negative potassium hydroxide (KOH) microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.

    Week 52

Secondary Outcomes (3)

  • Percentage of Participants With Clinical Effectiveness at the End of Study After Treating Patients for 48 Weeks.

    Week 52

  • Percentage of Participants With Mycological Cure at End of Study After Treating Patients for 48 Weeks

    Week 52

  • Safety and Tolerability Assessed by the Number of Participants With Adverse Events

    Week 52

Study Arms (2)

Terbinafine

EXPERIMENTAL

10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.

Drug: terbinafine hydrogen chloride

Amorolfine

ACTIVE COMPARATOR

5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.

Drug: amorolfine nail lacquer

Interventions

terbinafine hydrogen chlorideDRUG

10 % terbinafine hydrogen chloride (HCL)

Also known as: Lamisil
Terbinafine
amorolfine nail lacquerDRUG

5 % amorolfine nail lacquer

Amorolfine

Eligibility Criteria

Age12 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male and females 12 - 75 years of age
  • Fungal toenail infection of one or both of the large (great) toenails
  • The nail infection must be due to a dermatophyte, (mixed infections \[dermatophyte and non-dermatophyte\] are not allowed)
  • The target toenail area must have at least 25% to no more than 75% disease involvement without spikes.

You may not qualify if:

  • Target foot must not have severe plantar (moccasin) tinea pedis that would require systemic therapy. Mild to moderate tinea pedis (athlete's foot) infection should be treated with terbinafine prior to baseline or at any time during the trial. Other topical treatments for athlete's foot may be recommended at the discretion of the investigator.
  • Subjects must not have abnormalities of the nail that could prevent a normal appearing nail if clearing of infection is achieved
  • No administration of systemic antifungal medications within 6 months prior to screening visit
  • No application of prescription topical antifungal medications for toenail fungus within 3 months or other commercially available topical medications for toenail fungus applied directly to the toenails within 1 month prior to screening visit
  • Patients with the target toenail involving the matrix (lunula) or having less than 2mm clear (unaffected) nail plate length beyond the proximal fold.
  • Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail.
  • No professional pedicures or application of any nail polish product or nail cosmetic to the toenails after the screening visit
  • Known pregnancy or lactation at time of enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Novartis Investigative Site

Various Cities, Finland

Location

Novartis Investigative Site

Various Cities, France

Location

Novartis Investigative Site

Various Cities, Germany

Location

Novartis Investigative Site

Various Cities, Hungary

Location

Novartis Investigative Site

Various Cities, Iceland

Location

Novartis Investigative Site

Various Cities, Norway

Location

Novartis Investigative Site

Various Cities, Poland

Location

Novartis Investigative Site

Various Cities, Russia

Location

Novartis Investigative Site

Various Cities, Spain

Location

Novartis Investigative Site

Various Cities, Turkey (Türkiye)

Location

MeSH Terms

Conditions

OnychomycosisFoot Dermatoses

Interventions

Terbinafine

Condition Hierarchy (Ancestors)

TineaDermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousNail DiseasesSkin DiseasesSkin and Connective Tissue DiseasesFoot Diseases

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
862 778-8300

Study Officials

  • Novartis

    Novartis

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 10, 2007

First Posted

April 12, 2007

Study Start

March 1, 2007

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

May 6, 2011

Results First Posted

April 20, 2011

Record last verified: 2011-05

Locations

FI(1)DE(1)TU(1)FR(1)NO(1)HU(1)PL(1)RU(1)ES(1)IC(1)