Treatment of toenail onychomycosis with oral terbinafine plus aggressive debridement IRON-CLAD, a large, randomized, open-label, multicenter trial

Journal of the American Podiatric Medical Association

Volumn 96, Issue 6, 2006, Pages 465-473

  Jennimgs, Maureen B ^a,b   Pollak, Richard ^c   Harkless, Lawrence B ^d   Kianifard, Farid ^e   Tavakkol, Amir ^e  

^a NEW YORK COLLEGE OF PODIATRIC MEDICINE   (United States)

^b Jennings Institute for Clinical Research   (United States)

^c San Antonio Podiatry Associates   (United States)

^d UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO   (United States)

^e NOVARTIS PHARMA AG   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 33845332998     PISSN: 87507315     EISSN: None     Source Type: Journal    
DOI: 10.7547/0960465     Document Type: Article

References (26)

1. LUBECK DP, PATRICK DL, MCNULTY P, ET AL: Quality of life of persons with onychomycosis. Qual Life Res 2: 341, 1993.
2. DUPUY A, BENCHIKHI H, ROUJEAU JC, ET AL: Risk factors for erysipelas of the leg (cellulitis): case-control study. Br Med J 318: 1591, 1999.
3. ROUJEAU JC, SIGURGEIRSSON B, KORTING HC, ET AL: Chronic dermatomycoses of the foot as risk factors for acute bacterial cellulitis of the leg: a case-control study. Dermatology 209: 301, 2004.
4. GUPTA AK, SHEAR NH: A risk-benefit assessment of the newer oral antifungal agents used to treat onychomycosis. Drug Safety 22: 33, 2000.
5. GUPTA AK, MALKIN KF: Ciclopirox nail lacquer and podiatric practice. JAPMA 90: 502, 2000.
6. ROBBINS JM: Treatment of onychomycosis in the diabetic patient population. J Diabetes Compl 17: 98, 2003.
7. BARAN R, FEUILHADE M, COMBERNALE P, ET AL: A randomized trial of amoroline 5% solution nail lacquer combined with oral terbinafine compared with terbinafine alone in the treatment of dermatophytic toenail onychomycoses affecting the matrix region. Br J Dermatol 142: 1177, 2000.
8. DRACHMAND ZM: A method for the determination of drug effectiveness in onychomycosis. J Am Acad Dermatol 9: 912, 1983.
9. JENNINGS M, HARKLESS LB, POLLAK RA: Quantitation of visibly infected nail area in onychomycosis utilizing the mycotic nail involvement assessment [abstract]. Presented at the Annual Scientific Meeting of the American Podiatric Medical Association, August 24, 2004, Boston.
10. Lamisil [prescribing information], Novartis Pharmaceutical Corp, East Hanover, NJ, May 2004.
11. STOKES ME, DAVIS CS, KOCH GG: Categorical Data Analy sis Using the SAS System, 2nd Ed, SAS Institute Inc, Cary, NC, 2000.
12. BRÅUTIGAM M, NOLTING S, SCHOPF RE, ET AL: German randomized double-blind multicentre comparison of terbinafine and itraconazole for the treatment of toenail tinea infection. Br J Dermatol 134 (suppl 46): 18, 1996.
13. DE BACKER M, DE KAYSER P, DE VROEY C, ET AL: A 12-week treatment for dermatophyte toe onychomycosis: terbinafine 250 mg/day vs itraconazole 200 mg/day: a double-blind comparative trial. Br J Dermatol 134 (suppl 46): 16, 1996.
14. SIGURGEIRSSON B, ÓLAFSSON JH, STEINSSON J, ET AL: Long-term effectiveness of treatment with terbinafine vs itraconazole in onychomycosis: a 5-year blinded prospective follow-up study. Arch Dermatol 138: 353, 2002.
15. BRÄUTIGAM M, MOLTING S, SCHOPF RE, ET AL: Randomized double-blind comparison of terbinafine and itraconazole in the treatment of toenail tinea infection. Br Med J 311: 919, 1995.
16. POLLAK R, BILLSTEIN SA: Efficacy of terbinafine for toenail onychomycosis: a multicenter trial of various treatment durations. JAPMA 91: 127, 2001.
17. GOODFIELD MJ, ANDREW L, EVANS EG: Short term treatment of dermatophyte onychomycosis with terbinafine. Br Med J 304: 1151, 1992.
18. DEBACKER M, DEVROEY C, LESAFFRE E, ET AL: Twelve weeks of continuous oral therapy for toenail onychomycosis caused by dermatophytes: a double-blind, comparative trial of terbinafine 250 mg/day versus itraconazole 200 mg/day. J Am Acad Dermatol 38: S57, 1998.
19. GUPTA AK, RYDER JE, TAVAKKOL A: The use of terbinafine in the treatment of onychomycosis in adults and special patient populations: a review of the evidence. J Drugs Dermatol 4: 302, 2005.
20. ARNOLD B, KIANIFARD F, TAVAKKOL A: A comparison of KOH and culture results from two mycology laboratories for the diagnosis of onychomycosis during a randomized, multicenter clinical trial: a subset study [letter]. JAPMA 95: 421, 2005.
21. SINGER MI, SHAPIRO LE, SHEAR NH: Cytochrome P-450 3A: interactions with dermatologic therapies. J Am Acad Dermatol 37: 765, 1997.
22. VICKERS AEM, SINCLAIR JR, ZOLLINGER M, ET AL: Multiple cytochrome P-450s involved in the metabolism of terbinafine suggest a limited potential for drug-drug interactions. Drug Metab Dispos 27: 1029, 1999.
23. ELEWSKI B, TAVAKKOL A: Safety and tolerability of oral antifungal agents in the treatment of fungal nail disease: a proven reality. Clin Ther Risk Manage 1: 299, 2005.
24. GUPTA AK, KATZ I, SHEAR NH: Drug interactions with itraconazole, fluconazole, and terbinafine and their management. J Am Acad Dermatol 41: 237, 1999.
25. HALL M, MONKA C, KRUPP P, ET AL: Safety of oral terbinafine: results of a postmarketing surveillance study in 25,884 patients. Arch Dermatol 133: 1213, 1997.
26. TAVAKKOL A, FELLMAN S, KIANIFARD F: Safety and efficacy of oral terbinafine in the treatment of onychomycosis: analysis of the elderly subgroup in the open-label, randomized Improving Results in Onychomycosis Concomitant Lamisil® and Debridement (IRON-CLAD®) trial. Am J Geriatr Pharmacol 4: 1, 2006.