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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,029
10 % terbinafine hydrogen chloride (HCL)
5 % amorolfine nail lacquer
Novartis Investigative Site
Various Cities, Finland
Novartis Investigative Site
Various Cities, France
Novartis Investigative Site
Various Cities, Germany
Novartis Investigative Site
Various Cities, Hungary
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
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
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
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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Novartis Investigative Site
Various Cities, Iceland
Novartis Investigative Site
Various Cities, Norway
Novartis Investigative Site
Various Cities, Poland
Novartis Investigative Site
Various Cities, Russia
Novartis Investigative Site
Various Cities, Spain
Novartis Investigative Site
Various Cities, Turkey (Türkiye)