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Evaluation of the Appearance of Nail Polish Following Daily Treatment of Ex Vivo Human Fingernails With Topical Solutions of Tavaborole or Efinaconazole Tracey Vlahovic, DPM ; Dina Coronado, BS ; Sanjay Chanda, PhD ; Tejal Merchant, MPharm ; Lee Zane, MD 1 1 Introduction • Onychomycosis is a common fungal infection of the nail unit that can cause brittleness and discoloration of the nail and negatively impact patient self-image.1,2 ––Given that complete healthy nail regrowth can take up to 18 months, patients may choose to mask infected, discolored nails with polish.2 ––Until recently, the only US Food and Drug Administration (FDA)-approved topical treatment for onychomycosis was ciclopirox nail lacquer, 8%.3 • Two topical pharmacotherapies for the treatment of toenail onychomycosis caused by Trichophyton rubrum and T. mentagrophytes were recently approved by the FDA. 2 2 2 2 Temple University Hospital, Philadelphia, PA, USA; Anacor Pharmaceuticals, Inc., Palo Alto, CA, USA 2 Results Figure 3. Color Transfer From Solution Applicators to White Watercolor Paper Figure 1. Appearance of Polished Nails Treated With Tavaborole Topical Solution, 5% or Efinaconazole Topical Solution, 10% Tavaborole Topical Solution, 5% Tavaborole Applicator Efinaconazole Applicator Conclusions • Daily dropper application of tavaborole topical solution, 5% to ex vivo polished nails did not result in nail polish discoloration during the 7-day treatment period. ––Dropper applicators for tavaborole topical solution, 5% did not change in appearance during the treatment period, and no color transfer from the polished nails was evident on the watercolor paper or in the residual solution at the end of the study. Efinaconazole Topical Solution, 10% Day 1 Day 0 • Brush application of efinaconazole topical solution, 10% resulted in substantial polish changes from the initial application and polish transfer from nails to brush applicators. (Pre-dose) ––Discoloration became progressively worse over 7 days of treatment and was further evidenced by polish color transfer from nails to the watercolor paper and in the residual solution at the end of the study. ––Kerydin® (tavaborole) topical solution, 5% (Anacor Pharmaceuticals, Inc., Palo Alto, CA)a is a novel, boron-based, small-molecule pharmaceutical that was approved in July 2014.4 ––Jublia (efinaconazole topical solution, 10%; Valeant Pharmaceuticals, LLC, Bridgewater, NJ) was approved in June 2014.5 ® ––The package inserts for these products state that the impact of nail polish or other cosmetic nail products on the efficacy of the product has not been evaluated.4,5 Day 1 • These results suggest that topical treatment with tavaborole topical solution, 5% does not alter the drug applicator or the appearance of nail polish. Day 4 (First dose) • The clinical significance of these ex vivo data is unknown. • Previous studies have shown penetration of tavaborole topical solution, 5% through the nail plate in the presence of up to 4 layers of home or salon brand nail polish.6 References Objectives • The objectives of this study were to evaluate: ––The appearance of nail polish after daily dosing with the specific applicators used for tavaborole topical solution, 5% (dropper applicator) and efinaconazole topical solution, 10% (brush applicator). 1. Elewski BE. Int J Dermatol. 1997;36:754-6. Day 4 2. Thomas J, et al. J Clin Pharm Ther. 2010;35:497-519. Day 7 3. Penlac [package insert]. Bridgewater, NJ: Dermik Laboratories, a division of sanofi-aventis U.S. LLC; 2006. 4. Kerydin [package insert]. Palo Alto, CA: Anacor Pharmaceuticals, Inc.; 2015. 5. Jublia [package insert]. Bridgewater, NJ: Valeant Pharmaceuticals North America, LLC; 2015. ––The appearance of each of the two applicators after daily dosing of tavaborole topical solution, 5% or efinaconazole topical solution, 10% on polished nails. ––The presence of any color transfer from the respective applicators after dosing polished nails. Figure 4. Appearance of Drug Solutions at Day 7 (End of Study) Day 7 Tavaborole Topical Solution, 5% Methods • The study included a sample of 12 ex vivo, non-diseased human fingernails from 4 human cadaver donors. • Overall, nails were similar at baseline with regard to characteristics of nail length (range: 10.02–12.06 mm), nail width (range: 9.95–14.39 mm), and nail thickness (range: 0.31–0.85 mm). • Nails were cleaned, polished with 2 coats of L’Oreal Nail Color (Devil Wears Red #420) nail polish, and mounted on floral foam. 6. Elewski BE, et al. An in vitro study demonstrating nail penetration of tavaborole from tavaborole topical solution, 5% through multiple layers of nail polish. Poster presented at the Fall Clinical Dermatology Conference, October 16–19, 2014, Las Vegas, NV. Efinaconazole Topical Solution, 10% This study was sponsored by Anacor Pharmaceuticals, Inc., Palo Alto, CA, USA. Medical writing and editorial assistance was provided by Callie Grimes, PhD and Chad Williamson, MS, MBA of Echelon Brand Communications, Parsippany, NJ, USA, and was funded by Anacor Pharmaceuticals, Inc. Tracey Vlahovic has received honoraria as a speaker for Anacor Pharmaceuticals, Inc. and as an advisory board member for Merz Pharma and Valeant Pharmaceuticals. Dina Coronado, Sanjay Chanda, Tejal Merchant, and Lee Zane are employees of Anacor Pharmaceuticals, Inc. Figure 2. Appearance of Tavaborole Dropper and Efinaconazole Brush After Treatment Application Day 0 (Pre-dose) Day 1 Day 4 Day 7 • Nails were randomly assigned to treatment with tavaborole topical solution, 5% applied with dropper once daily for 7 days or efinaconazole topical solution, 10% applied with brush once daily for 7 days, as per their respective patient instructions. Fougera Pharmaceuticals Inc., a Sandoz Inc. company is responsible for marketing Kerydin® (tavaborole) topical solution, 5%. a • Dropper and brush applicators used to apply medications were applied to white watercolor paper immediately after dosing nails to evaluate the presence of color transfer from the polish. • Nails, applicators, and watercolor papers were photographed daily following application to document qualitative appearance. Financial Disclosures Tavaborole dropper Efinaconazole brush applicator Tavaborole dropper Efinaconazole brush applicator Tavaborole dropper Efinaconazole brush applicator Tavaborole dropper Efinaconazole brush applicator Dosed Control Dosed Control