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#242 Putting the FUN in Fungi: Toenail onychomycosis treatments

How effective are treatments for mild-moderate adult toenail onychomycosis?

Up to 45-60% of patients on oral treatments (terbinafine best), 6-23% on topicals (efinaconazole best), and <10% on placebo will be “cured” after ~1 year.  Topicals should be reserved for cases with minimal (<40%) nail involvement.  

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Oral agents: 
  • Meta-analysis of 43 randomized, controlled trials (RCTs),19730 patients, example ~60-70% nail involvement2, 12-16 weeks treatment3. Rates of clinical cure after 4 months-2 years follow-up:1 
    • Terbinafine versus placebo, 8 RCTs: 48% terbinafine, 6% placebo, number needed to treat (NNT)=3. 
    • Azoles” (mostly itraconazole) versus placebo, 9 RCTs: 31% azole, 1.4% placebo, NNT=4. 
    • Terbinafine versus “azoles” (mostly itraconazole), 15 RCTs: 58% terbinafine, 46% azole; NNT=9. 
Topical ciclopirox:  
  • 3 RCTs, 928 patients, 48 weeks of treatment, ~40% nail involvement.4,5 
    • “Cure” (mycological and clinical cure): 6-8% ciclopirox, 0-1% placebo (NNT=15-23). 
Topical efinaconazole: 
  • 2 identical RCTs, 1655 patients.  48 weeks of treatment, assessed at 52 weeks, ~40% nail involvement:6 
    • “Complete cure” (mycological cure and 100% healthy nail): ~16%, ~4% placebo (NNT~9). 
  • RCT, 135 patients. After 36 weeks of treatment and 4 weeks follow-up, ~40% nail involvement:7 
    • “Complete cure” (mycological cure and 100% healthy nail): ~22%, 9% placebo (NNT=8). 
Other systematic reviews only reported mycological cure.8-10   Context: 
  • While British guidelines suggest laboratory confirmation before treatment;11 only 50% of Canadian guideline authors recommend this approach.12 
    • Culture results take several weeks and have ~35% false negative rate.13 
    • Fungal stains alone (without culture/histology) have low sensitivity.13 
  • Canadian guidelines suggest topical efinaconazole if <20% nail involvement, efinaconazole +/- oral terbinafine for 20-60% involvement (or for >3 nails), oral terbinafine for >60% involvement.12 
  • Risk of terbinafine-induced liver injury: ~1 in 50,000-120,000 prescriptions.14 
  • Medication Costs:15 
    • Oral (12 weeks): 
      • Terbinafine: ~$90 
      • Itraconazole: ~$850  
    • Topical (48 weeks): 2 bottles per treatment.  
      • Ciclopirox: ~$150 
      • Efinaconazole: ~$250 
  • Terbinafine treatment without confirmatory testing is likely most cost-effective approach.16 
  • Although not always statistically different, some RCTs found clinically relevant improvements with 4-6-month oral treatment regimens compared to 3 months.3,17 

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  • Adrienne J Lindblad BSP ACPR PharmD
  • Stacy Jardine BScPharm
  • Michael R Kolber MD CCFP MSc

1. Kreijkamp-Kaspers S, Hawke K, Guo L, et al. Cochrane Database System Rev. 2017;7:CD010031.

2. Evans EG, Sigurgeirsson B. BMJ. 1999 Apr 17; 318(7190):1031-5.

3. Drake LA, Shear NH, Arlette JP, et al. J Am Acad Dermatol. 1997; 37:740-5.

4. Gupta AK, Fleckman P, Baran R. J Am Acad Dermatol. 2000; 43(4):S70-79.

5. Baran R, Tosti A, Hartmane I, et al. JEADV. 2009; 23:773-81.

6. Elewski BW, Rich P, Pollak R, et al. J Am Acad Dermatol. 2013; 68:600-8.

7. Tschen EH, Bucko AD, Oizumi N, et al. J Drugs Dermatol. 2013; 12(2):186-92.

8. Gupta AK, Foley KA, Mays RR, et al. Br J Dermatol. 2019 May 23 [Epub ahead of print].

9. Gupta AK, Daigle D, Paquet M. J American Podiatric Med Assoc 2015; 105(4):357-366.

10. Crawford S, Hollis S. Cochrane Database System Rev. 2007; 3:CD001434.

11. Ameen M, Lear JT, Madan V, et al. Br J Dermatol. 2014; 171:937-958.

12. Gupta AK, Sibbald RG, Andriessen A, et al. J Cut Med Surg. 2015; 19(5):440-9.

13. Gupta AK, Versteeg SG, Shear NH. J Cut Med Surg. 2017; Vol.21(6):525-539.

14. Albrecht J, Kramer ON. Br J Dermatol. 2017; 177:1279-84.

15. Calculations using data from Alberta Health Interactive Drug Benefit List. Available at: Accessed June 7, 2019.

16. Mikailov A, Cohen J, Joyce C, et al. JAMA Dermatol. 2016; 152(3):276-281.

17. Heikkila H, Stubb S. Br J Dermatol. 2002; 146:250-3.

Authors do not have any conflicts of interest to declare.

Les auteurs n’ont aucun conflit d’intérêts à déclarer.