Clinical trial NCT00459537: Efficacy, Safety and Tolerability of Topical 10% Terbinafine Hydrogen Chloride Versus 5% Amorolfine Nail Lacquer in Patients With Mild to Moderate Toenail Onychomycosis
Official title: A Randomized, Open-label, Active-controlled, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Topical 10% Terbinafine Hydrogen Chloride (HCl) Formulation Versus 5% Amorolfine Nail Lacquer for 48 Weeks of Treatment in Patients With Mild to Moderate Toenail Onychomycosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Onychomycosis
Keywords: Toenail fungus
Onychomycosis
Nail fungus
Toenail fungal infection
Tinea unguium
Dermatophytes
Foot dermatoses
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-04-12
Enrollment: 1029
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Percentage of Participants With Complete Cure at the End of Study After Treating Participants for 48 Weeks
timeFrame: Week 52
measure: Percentage of Participants With Complete Cure at the End of Study After Treating Participants for 48 Weeks.
timeFrame: Week 52
Secondary outcomes:
measure: Percentage of Participants With Clinical Effectiveness at the End of Study After Treating Patients for 48 Weeks.
timeFrame: Week 52
measure: Percentage of Participants With Mycological Cure at End of Study After Treating Patients for 48 Weeks
timeFrame: Week 52
measure: Safety and Tolerability Assessed by the Number of Participants With Adverse Events
timeFrame: Week 52
Other outcomes:
Locations:
city: Various Cities
country: Finland
facility: Novartis Investigative Site
city: Various Cities
country: France
facility: Novartis Investigative Site
city: Various Cities
country: Germany
facility: Novartis Investigative Site
city: Various Cities
country: Hungary
facility: Novartis Investigative Site
city: Various Cities
country: Iceland
facility: Novartis Investigative Site
city: Various Cities
country: Norway
facility: Novartis Investigative Site
city: Various Cities
country: Poland
facility: Novartis Investigative Site
city: Various Cities
country: Russian Federation
facility: Novartis Investigative Site
city: Various Cities
country: Spain
facility: Novartis Investigative Site
city: Various Cities
country: Turkey
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References: