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Efficacy and safety of tavaborole topical solution, 5%, a novel boron-based antifungal agent, for the treatment of toenail onychomycosis: Results from 2 randomized phase-III studies - 17/06/15

Doi : 10.1016/j.jaad.2015.04.010 
Boni E. Elewski, MD a, , Raza Aly, PhD b, Sheryl L. Baldwin, RN c, Remigio F. González Soto, MD d, Phoebe Rich, MD e, Max Weisfeld, DPM f, Hector Wiltz, MD, CPI g, Lee T. Zane, MD d, Richard Pollak, DPM, MS h
a Department of Dermatology, University of Alabama at Birmingham, Birmingham, Alabama 
b Department of Dermatology, University of California, San Francisco, California 
c Anacor Pharmaceuticals, Inc, Palo Alto, California 
d Centro de Dermatologia de Monterrey, Monterrey, Mexico 
e Oregon Health and Science University, Portland, Oregon 
f Hamilton Foot Care, Baltimore, Maryland 
g FXM Research Corp, Miami, Florida 
h Endeavor Clinical Trials, San Antonio, Texas 

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

Abstract

Background

Onychomycosis, a fungal nail infection, can impact quality of life.

Objective

We sought to evaluate the efficacy and safety of tavaborole topical solution, 5% for treatment of toenail onychomycosis.

Methods

In 2 phase-III trials, adults with distal subungual onychomycosis affecting 20% to 60% of a target great toenail were randomized 2:1 to tavaborole or vehicle once daily for 48 weeks. The primary end point was complete cure of the target great toenail (completely clear nail with negative mycology) at week 52. Secondary end points included completely or almost clear nail, negative mycology, completely or almost clear nail plus negative mycology, and safety.

Results

Rates of negative mycology (31.1%-35.9% vs 7.2%-12.2%) and complete cure (6.5% and 9.1% vs 0.5% and 1.5%) significantly favored tavaborole versus vehicle (P ≤ .001). Completely or almost clear nail rates also significantly favored tavaborole versus vehicle (26.1%-27.5% vs 9.3%-14.6%; P < .001). Rates of completely or almost clear nail plus negative mycology (15.3%-17.9% vs 1.5%-3.9%) were significantly greater for tavaborole versus vehicle (P < .001). Application-site reactions with tavaborole included exfoliation (2.7%), erythema (1.6%), and dermatitis (1.3%).

Limitations

Duration of follow-up is a limitation.

Conclusion

Tavaborole demonstrates a favorable benefit-risk profile in treatment of toenail onychomycosis.

Le texte complet de cet article est disponible en PDF.

Key words : antifungal agents, arthrodermataceae, nails, onychomycosis, randomized controlled trial, tavaborole

Abbreviations used : AE, FDA, KOH, TEAE, TGT, tRNA


Plan


 Writing and editorial assistance was provided by Callie Grimes of Peloton Advantage, LLC, Parsippany, NJ, and was supported by Anacor Pharmaceuticals, Inc. Diane Nelson of Anacor Pharmaceuticals, Inc, provided critical review and revision of the manuscript.
 Disclosure: Ms Baldwin and Dr Zane are employees of Anacor Pharmaceuticals, Inc. Dr Elewski has received honoraria and grants while serving as a consultant and investigator with the following companies: Anacor Pharmaceuticals, Inc; Valeant Pharmaceuticals International Inc, Bridgewater, NJ; and Meiji Seika Pharma Co, Ltd, Tokyo, Japan. Dr Aly was consultant and investigator for Anacor Pharmaceuticals, Inc. Dr González Soto was an investigator for the following companies: Anacor Pharmaceuticals, Inc; Pfizer, New York, NY; and Eli Lilly, Indianapolis, IN. Dr Rich was the principal investigator for onychomycosis studies with the following companies: Anacor Pharmaceuticals, Inc; Topica Pharmaceuticals, Los Altos, CA; Valeant Pharmaceuticals International Inc; and Viamet Pharmaceuticals Inc, Durham, NC. Dr Pollak has received grants and honoraria while serving as advisory board member, investigator, and speaker for the following companies: Anacor Pharmaceuticals, Inc; Valeant Pharmaceuticals International Inc; and Topica Pharmaceuticals. Drs Weisfeld and Wiltz were principal investigators for Anacor Pharmaceuticals, Inc. The authors were 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.


© 2015  American Academy of Dermatology, Inc.. Publié par Elsevier Masson SAS. Tous droits réservés.
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Vol 73 - N° 1

P. 62-69 - juillet 2015 Retour au numéro
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