Efficacy and safety of topical terbinafine 10% solution (MOB-015) in the treatment of mild to moderate distal subungual onychomycosis: A randomized, multicenter, double-blind, vehicle-controlled phase 3 study - 03/09/20
, Maria S. Surprenant, DPM c, Steven E. Kempers, MD d, David M. Pariser, MD e, Kjell Rensfeldt, MD f, Amir Tavakkol, PhD g, ⁎ Cet article a été publié dans un numéro de la revue, cliquez ici pour y accéder
Abstract |
Background |
Onychomycosis is a recalcitrant fungal nail infection. Topical antifungal agents may be preferred over systemic agents due to lack of systemic adverse effects.
Objective |
To investigate the efficacy and safety of topical terbinafine 10% solution (MOB-015) for the treatment of distal and lateral subungual onychomycosis.
Methods |
In a multicenter, double-blind, phase III, North American study, patients with mild to moderate distal and lateral subungual onychomycosis involving 20% to 60% of at least 1 great toenail were randomized to once daily application of MOB-015 or matching vehicle for 48 weeks. The primary efficacy variable was complete cure, while the secondary efficacy variables were mycological cure and treatment success. Safety evaluations were also performed.
Results |
At week 52, the mycological cure (negative culture and potassium hydroxide microscopy) rate in the MOB-015 and vehicle groups was 69.9% and 27.7%, respectively (P < .001), and complete cure (0% clinical disease involvement and mycological cure) was achieved in 4.5% and 0% of patients, respectively (P = .0195). At least 1 adverse event leading to discontinuation of treatment occurred in 2.8% of patients in the MOB-015 group and in 4.2% in the vehicle group.
Limitation |
The follow-up period after end of treatment may not be sufficient to accurately reflect cure in distal and lateral subungual onychomycosis.
Conclusions |
MOB-015 is a treatment option for onychomycosis with an adverse event profile similar to vehicle.
Le texte complet de cet article est disponible en PDF.Key words : antifungal, MOB-015, onychomycosis, terbinafine topical
Abbreviations used : AE, DSO, FAS, KOH, MOB-015
Plan
| Funding sources: The study was supported by Moberg Pharma AB, Bromma, Sweden. |
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| Conflicts of interest: Dr Gupta is an advisor to Moberg Pharma, Bausch Health (Canada), and Ortho Dermatologics, and is an investigator for Bausch Health (Canada). Dr Rensfeldt is a consultant and was an employee of Moberg Pharma, Bromma, Sweden. Dr Tavakkol is an employee of Moberg Pharma. Drs Gupta, Surprenant, Kempers, and Pariser were investigators in the MOB-015 study. The authors are fully responsible for the content, editorial decisions, and opinions expressed in the current article. No author received an honorarium related to the development of this manuscript. Drs Surprenant, Kempers, and Pariser have no conflicts of interest to declare. |
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| IRB approval status: This study received Institutional Review Board approval and was executed using Good Clinical Practices as per the FDA and International Conference on Harmonization guidelines. |
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