Download Ex Vivo Human Fingernails With Topical Solutions

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
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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