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Efinaconazole 10% solution in the treatment of toenail onychomycosis: Two phase III multicenter, randomized, double-blind studies - 21/03/13

Doi : 10.1016/j.jaad.2012.10.013 
Boni E. Elewski, MD a, , Phoebe Rich, MD b, Richard Pollak, DPM c, David M. Pariser, MD d, Shinichi Watanabe, MD e, Hisato Senda, DVM f, Chikara Ieda, PharB g, Kathleen Smith, MBA h, Radhakrishnan Pillai, PhD h, Tage Ramakrishna, MD i, Jason T. Olin, PhD i
a Department of Dermatology, University of Alabama at Birmingham School of Medicine, Birmingham, Alabama 
b Northwest Cutaneous Research Specialists, Portland, Oregon 
c San Antonio Podiatry Associates, San Antonio, Texas 
d Department of Dermatology, Eastern Virginia Medical School, Norfolk, Virginia 
e Department of Dermatology, Teikyo University School of Medicine, Tokyo, Japan 
f Kaken Pharmaceutical Co Ltd, Kyoto, Japan 
g Kaken Pharmaceutical Co Ltd, Tokyo, Japan 
h Dow Pharmaceutical Sciences Inc, (a division of Valeant Pharmaceuticals North America LLC) Petaluma, California 
i Valeant Pharmaceuticals North America LLC, Bridgewater, New Jersey 

Reprint requests: Boni E. Elewski, MD, Department of Dermatology, University of Alabama at Birmingham School of Medicine, EFH 414, 1530 3rd Ave S, Birmingham, AL 35294-0009.

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.
 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.


© 2012  American Academy of Dermatology, Inc.. Publié par Elsevier Masson SAS. Tous droits réservés.
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