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CompletedNCT00459537Updated May 6, 2011Results posted

Efficacy, Safety and Tolerability of Topical 10% Terbinafine Hydrogen Chloride Versus 5% Amorolfine Nail Lacquer in Patients With Mild to Moderate Toenail Onychomycosis

A Phase 3 interventional study of terbinafine hydrogen chloride and amorolfine nail lacquer in Onychomycosis, sponsored by Novartis. Completed at 10 sites in 10 countries. Open to participants aged 12 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-05-06.

Sponsored by Novartis · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,029
Allocation
Randomized
Ages
12 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Onychomycosis

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Keywords

  • Toenail fungus
  • Onychomycosis
  • Nail fungus
  • Toenail fungal infection
  • Tinea unguium
  • Dermatophytes
  • Foot dermatoses
03

In context

Onychomycosis

147 studies on the registry are indexed under Onychomycosis; 13 are open to participants now.

This study's enrollment of 1,029 is above the median of 56 across 134 interventional studies indexed under Onychomycosis.

Browse Onychomycosis studies →

Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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

Other protocol-defined inclusion/exclusion criteria may apply

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,029 participants (actual)

Study arms

  • Experimental
    Terbinafine

    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

  • Active comparator
    Amorolfine

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

    Drug: amorolfine nail lacquer

Interventions

  • Drugterbinafine hydrogen chloride

    10 % terbinafine hydrogen chloride (HCL)

    Also known as: Lamisil

  • Drugamorolfine nail lacquer

    5 % amorolfine nail lacquer

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Week 52

  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.

    Time frame: Week 52

Secondary outcomes

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

    Clinical effectiveness is defined as negative KOH microscopy and negative culture for dermatophytes and \<= 10% residual involvement of the target toenail.

    Time frame: Week 52

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

    Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes

    Time frame: Week 52

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

    Safety and tolerability data as assessed by the number of participants with Adverse Events (AE), Serious Adverse Events, Drug discontinuation due to an AE or SAE and death. Additional details can be found in the Adverse Event Section.

    Time frame: Week 52

07

Results

Posted Apr 20, 2011

Participant flow

Participant flow — Overall Study
MilestoneTerbinafineAmorolfine
Started507522
Safety population493512
Completed441446
Not completed6676
Withdrew: Adverse event16
Withdrew: Lack of efficacy1011
Withdrew: Withdrawal by subject2026
Withdrew: Lost to follow-up2730
Withdrew: Administrative problems30
Withdrew: Protocol violation43
Withdrew: Missing10

Outcome measures

PrimaryPercentage 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.

Time frame:
Week 52
Reported as:
Number · Percentage of participants
Percentage of Participants With Complete Cure at the End of Study After Treating Participants for 48 Weeks
Percentage of participantsTerbinafineAmorolfine
Percentage of Participants With Complete Cure at the End of Study After Treating Participants for 48 Weeks1.180.96
SecondaryPercentage of Participants With Clinical Effectiveness at the End of Study After Treating Patients for 48 Weeks.

Clinical effectiveness is defined as negative KOH microscopy and negative culture for dermatophytes and \<= 10% residual involvement of the target toenail.

Time frame:
Week 52
Reported as:
Number · Percentage of participants
Percentage of Participants With Clinical Effectiveness at the End of Study After Treating Patients for 48 Weeks.
Percentage of participantsTerbinafineAmorolfine
Percentage of Participants With Clinical Effectiveness at the End of Study After Treating Patients for 48 Weeks.4.543.83
SecondaryPercentage of Participants With Mycological Cure at End of Study After Treating Patients for 48 Weeks

Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes

Time frame:
Week 52
Reported as:
Number · Percentage of participants
Percentage of Participants With Mycological Cure at End of Study After Treating Patients for 48 Weeks
Percentage of participantsTerbinafineAmorolfine
Percentage of Participants With Mycological Cure at End of Study After Treating Patients for 48 Weeks16.1715.71
SecondarySafety and Tolerability Assessed by the Number of Participants With Adverse Events

Safety and tolerability data as assessed by the number of participants with Adverse Events (AE), Serious Adverse Events, Drug discontinuation due to an AE or SAE and death. Additional details can be found in the Adverse Event Section.

Time frame:
Week 52
Reported as:
Number · Participants
Safety and Tolerability Assessed by the Number of Participants With Adverse Events
ParticipantsTerbinafineAmorolfine
At least 1 AE285291
AE suspected related to study drug117
At least 1 SAE918
SAE suspected related to study drug00
Death00
Drug discontinuation due to an AE15
PrimaryPercentage 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.

Time frame:
Week 52
Reported as:
Number · Percentage of participants
Percentage of Participants With Complete Cure at the End of Study After Treating Participants for 48 Weeks.
Percentage of participantsTerbinafineAmorolfine
Percentage of Participants With Complete Cure at the End of Study After Treating Participants for 48 Weeks.1.150.38

Adverse events

Collected over 52 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Terbinafine—9/493 (1.8%)186/493 (37.7%)
Amorolfine—18/512 (3.5%)168/512 (32.8%)
Most frequent serious events
Showing 10 of 33
Most frequent serious events
EventTerbinafineAmorolfine
Myocardial infarctionCardiac disorders0/4933/512
LymphadenopathyBlood and lymphatic system disorders1/4930/512
Enterovesical fistulaGastrointestinal disorders1/4930/512
CystitisInfections and infestations1/4930/512
DiverticulitisInfections and infestations1/4930/512
ErysipelasInfections and infestations1/4930/512
PyelonephritisInfections and infestations1/4930/512
OsteoarthritisMusculoskeletal and connective tissue disorders1/4930/512
Cyst removalSurgical and medical procedures1/4930/512
Dupuytren's contracture operationSurgical and medical procedures1/4930/512
Most frequent other events
Most frequent other events
EventTerbinafineAmorolfine
HeadacheNervous system disorders98/49370/512
NasopharyngitisInfections and infestations69/49365/512
Tinea pedisInfections and infestations29/49333/512
Back painMusculoskeletal and connective tissue disorders26/49329/512
InfluenzaInfections and infestations25/49315/512

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)TerbinafineAmorolfineTotal
<=18 years011
Between 18 and 65 years425410835
>=65 years82111193
Sex: Female, Male
Sex: Female, Male(Participants)TerbinafineAmorolfineTotal
Female158150308
Male349372721
08

Study locations

10 sites
  • Novartis Investigative Site
    Various Cities, Finland
  • Novartis Investigative Site
    Various Cities, France
  • Novartis Investigative Site
    Various Cities, Germany
  • Novartis Investigative Site
    Various Cities, Hungary
  • Novartis Investigative Site
    Various Cities, Iceland
  • Novartis Investigative Site
    Various Cities, Norway
  • Novartis Investigative Site
    Various Cities, Poland
  • Novartis Investigative Site
    Various Cities, Russian Federation
  • Novartis Investigative Site
    Various Cities, Spain
  • Novartis Investigative Site
    Various Cities, Turkey
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00459537
Lead sponsor
Novartis
First posted
Apr 12, 2007
Start date
Mar 2007
Primary completion
Jan 2009
Completion
Jan 2009
Results posted
Apr 20, 2011
Last update
May 6, 2011

Study contacts

Novartis
study director · Novartis
View the source record on ClinicalTrials.gov ↗

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