An Open-Label, Multi-Center, Multiple-Application Pharmacokinetic Study of Naftifine HCl Gel 2% in Pediatric Subjects With Tinea Pedis

July 2015 | Volume 14 | Issue 7 | Original Article | 686 | Copyright © July 2015


Amit Verma DrPH MPH, Babajide Olayinka MSc, Alan B. Fleischer Jr. MD

Merz North America, Inc., Raleigh, NC

adult control subjects. Naftifine hydrochloride gel 2% was well tolerated during the 14-day treatment period. Only two pediatric subjects (9%) and one adult subject (17%) experienced a treatment emergent adverse event and in all cases these adverse events were found to be unrelated to treatment and resolved prior to the end of the study.
Overall, as demonstrated in this maximal use pharmacokinetic study, as well as previous clinical trials,19 naftifine hydrochloride gel 2% was found to be safe, well tolerated, and efficacious for the treatment of tinea pedis in a pediatric and adult population.

ACKNOWLEDGMENT

This research was supported and funded by Merz Pharmaceuticals, LLC.

DISCLOSURES

Amit Verma, Babajide Olayinka, and Alan B. Fleischer are all employees of Merz North America, Inc.

REFERENCES

  1. Noble SL, Forbes RC, Stamm PL. Diagnosis and management of common tinea infections. Am Fam Physician. 1998;58(1): 163-174.
  2. Weinstein A, Berman B. Topical treatment of common superficial tinea infection. Amer Fam Phys. 2002;65(10):2095-2103.
  3. Bell-Syer SE, Hart R, Crawford F, et al. Oral treatments for fungal infections of the skin of the foot. Cochrane Database Syst Rev. 2002: CD003584.
  4. Patel A, Brookman SD, Bullen MU, et al. Topical treatment for interdigital tinea pedis: terbinafine compared with clotrimazole. Australas J Dermatol. 1999, 40: 197-200.
  5. Hasan M, Fitzgerald SM, Saoudian M, et al. Dermatology for the practicing allergist: Tinea pedis and its complications. Clinical and Molecular Allergy. 2004, 2:5.
  6. Pray WS. Nonprescription Product Therapeutics. 2nd ed. Baltimore, MD: Lippincott Williams & Wilkins; 2006.
  7. Pray WS, Pray J. Tinea cruris in men: Bothersome but treatable. [Electronic version]. U.S. Pharmacist. 2005; 30(9).
  8. Gupta A, Ryder J, Chow M, et al. Dermatophytosis: The management of fungal infections. SKINmed. 2005;4(5): 305-310.
  9. Masri-Fridling GD. Dermatophytosis of the feet. Dermatol Clin. 1996 ;14(1): 33-40.
  10. Markova T. Clinical inquiries. What is the most effective treatment for tinea pedis (athlete’s foot)? J Fam Pract. 2002 ;51(1):21-7.
  11. Andrews MD, Burns M. Common tinea infections in children. Am Fam Physician. 2008;77(10):1415-20.
  12. Naftin® (naftifine HCl, 2%) Gel Prescribing Information, Rev 6/2013.
  13. Naftin® (naftifine HCl, 2%) Cream Prescribing Information, Rev 1/2012.
  14. Evans EG, James IG, Seaman RA, et al. Does naftifine have anti-inflammatory properties? A double-blind comparative study with 1% clotrimazole/1% hydrocortisone in clinically diagnosed fungal infection of the skin. Br J Dermatol. 1993;129 (4):437-442.
  15. Merz Pharmaceuticals, LLC. Naftifine product monograph. 2010.
  16. Monk JP, Brogden RN. Naftifine: a review of its antimicrobial activity and therapeutic use in superficial dermatomycoses. Drugs. 1991;42(4):659-72.
  17. Parish LC, Parish JL, Routh HB, et al. A randomized, double-blind, vehicle-controlled efficacy and safety study of naftifine 2% cream in the treatment of tinea pedis. J Drugs Dermatol. 2011;10(11):1282-88.
  18. Parish LC, Parish JL, Routh HB, et al. A double-blind, randomized, vehicle-controlled study evaluating the efficacy and safety of naftifine cream, 2% in tinea cruris. J Drugs Dermatol. 2011;10(10):1142-48.
  19. Stein Gold L, Parish LC, Vlahovic T, et al. efficacy and Safety of Naftifine HCl Gel 2% in the Treatment of Interdigital and Moccasin Type Tinea Pedis: Pooled Results from Two Multicenter, Randomized, Double-Blind, Vehicle-Controlled Trials. J Drugs Dermatol.. 2013; 12(8): 911-918.
  20. Plaum S, Verma A, Fleischer A, et al. Detection and relevance of Naftifine Hydrochloride in the Stratum Corneum Up to Four Weeks Following the Last Application of Naftifine Cream and Gel, 2%. J Drugs Dermatol. 2013; 12(9): 1004-1008.

AUTHOR CORRESPONDENCE

Amit Verma DrPH MPH……....................................amit.verma@merz.com
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