Efinaconazole 10% solution in the treatment of toenail onychomycosis: Two phase III multicenter, randomized, double-blind studies - 21/03/13
Abstract |
Background |
Onychomycosis is a common nail infection, often resulting in nail plate damage and deformity. Topical lacquer treatments have negligible efficacy. Oral treatments, although more efficacious, are limited by drug interactions and potential hepatotoxicity.
Objective |
We investigated the safety and efficacy of efinaconazole 10% solution (efinaconazole), the first triazole antifungal developed for distal lateral subungual onychomycosis.
Methods |
Two identical, multicenter, randomized, double-blind, vehicle-controlled studies were conducted in patients with toenail distal lateral subungual onychomycosis (20%-50% clinical involvement [study 1: N = 870, study 2: N = 785]). Patients were randomized (3:1) to efinaconazole or vehicle, once daily for 48 weeks, with 4-week posttreatment follow-up. Debridement was not performed. The primary end point was complete cure rate (0% clinical involvement of target toenail, and both negative potassium hydroxide examination and fungal culture) at week 52.
Results |
Mycologic cure rates were significantly greater with efinaconazole (study 1: 55.2%, study 2: 53.4%) compared with vehicle (P < .001). The primary end point, complete cure, was also significantly greater for efinaconazole (study 1: 17.8% vs 3.3%, study 2: 15.2% vs 5.5%, P < .001). Treatment success (percent affected target toenail [0%-≤10%]) for efinaconazole ranged from 21.3% to 44.8% in study 1 and from 17.9% to 40.2% in study 2, compared with 5.6% to 16.8% and 7.0% to 15.4%, respectively, with vehicle. Adverse events associated with efinaconazole were local site reactions (2%) and clinically similar to vehicle.
Limitations |
A period of 52 weeks may be too brief to evaluate a clinical cure in onychomycosis.
Conclusions |
Once daily topical efinaconazole appears to be a viable alternative to oral treatment options for onychomycosis.
Le texte complet de cet article est disponible en PDF.Key words : efficacy, efinaconazole, onychomycosis, randomized controlled trials, safety, topical triazole antifungal
Plan
Supported by Valeant Pharmaceuticals North America LLC, Bridgewater, NJ. Editorial assistance was provided by Brian Bulley, MSc, of Inergy Limited, whose fees were paid by Valeant Pharmaceuticals North America LLC. |
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Disclosure: Dr Elewski was an advisor to Valeant Dermatology, a subsidiary of Valeant Pharmaceuticals North America LLC. Dr Watanabe was a consultant to Kaken Pharmaceuticals Co Ltd, Hisamitsu Pharmaceutical Co Inc, and Sato Pharmaceutical Co Ltd. Dr Rich was an investigator with Anacor, Celtic Pharma, Cipher Pharmaceuticals, Nitric Bio Inc, and Promius Pharma LLC, and an advisor for Valeant Dermatology, a subsidiary of Valeant Pharmaceuticals North America LLC. Dr Pariser was a consultant to Valeant Dermatology, a subsidiary of Valeant Pharmaceuticals North America LLC, Abbott Laboratories, Amgen, Astellas Pharma US Inc, Celgene Corp, DUSA Pharmaceuticals, Galderma Laboratories LP, and Genetech Inc, and an investigator for Abbott Laboratories, Amgen, Basliea, Celgene Corp, Lilly and Company, Galderma Laboratories LP, Graceway Pharmaceuticals LLC, and Intendis Inc. Dr Pollak was an advisor to Valeant Dermatology, a subsidiary of Valeant Pharmaceuticals North America LLC. Drs Elewski, Watanabe, Rich, Pariser, and Pollak were all investigators in the efinaconazole studies. Dr Senda and Mr Ieda are employees and stockholders in Kaken Pharmaceuticals Co Ltd. Drs Ramakrishna, Pillai, Olin, and Ms Smith are employees and stockholders in Valeant Pharmaceuticals North America LLC. |
Vol 68 - N° 4
P. 600-608 - avril 2013 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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