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

Onychomycosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00459537
• Other study ID #: CSFO327N2303
• Status: Completed
• Phase: Phase 3
• First received: April 10, 2007
• Last updated: May 3, 2011
• Start date: March 2007
• Est. completion date: January 2009

Study information

• Verified date: May 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesHungary: Országos Gyógyszerészeti IntézetIceland: Icelandic Medicines Control AgencyNorway: Norwegian Medicines AgencyPoland: Central Register of Clinical TrialsRussia: Ministry of Health of the Russian FederationSpain: Ministry of HealthTurkey: T.C. Saglik Bakanligi
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1029
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Onychomycosis

Intervention

Drug:
• terbinafine hydrogen chloride
10 % terbinafine hydrogen chloride (HCL)
• amorolfine nail lacquer
5 % amorolfine nail lacquer

Locations

Country	Name	City	State
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	Novartis Investigative Site	Various Cities

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

Finland,  France,  Germany,  Hungary,  Iceland,  Norway,  Poland,  Russian Federation,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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.	Week 52	No
Secondary	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	Week 52	No
Secondary	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.	Week 52	Yes