British Association of Dermatologists' Guidelines for the Management of Onychomycosis 2014

M. Ameen; J.T. Lear; V. Madan; M.F. Mohd Mustapa; M. Richardson

The British Journal of Dermatology. 2014;171(5):937-958.

Purpose and Scope

The overall objective of the guideline is to provide up-to-date, evidence-based recommendations for the management of onychomycosis. The document aims to (i) offer an appraisal of all relevant literature since January 2002, focusing on any key developments; (ii) address important, practical clinical questions relating to the primary guideline objective, for example accurate diagnosis and identification of cases, and suitable treatment to minimize the duration of disease and discomfort; (iii) provide guideline recommendations and, where appropriate, with some health economic implications; and (iv) discuss potential developments and future directions.
The guideline is presented as a detailed review with highlighted recommendations for practical use in the clinic, in addition to an updated patient information leaflet [available on the British Association of Dermatologists' (BAD) website, www.bad.org.uk].

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Table 1. Summary of drug therapies in adults
Strength of recommendation	Treatment in adults	Contraindications and cautions	Suggested method of use and monitoring	Common adverse reactions
	Systemics
A	Itraconazole: first line of treatment for dermatophyte onychomycosis	Heart failure, hepatotoxicity	200 mg per day for 12 weeks continuously, or alternatively as 'pulse therapy' at a dose of 400 mg per day for 1 week per month. Two pulses are recommended for fingernails and three pulses for toenails. It is optimally absorbed with food and an acidic pH	Headache and gastrointestinal upset
		Heart failure, hepatotoxicity	Monitoring hepatic function tests is recommended in patients with pre-existing deranged results, in those receiving continuous therapy for more than a month, and with concomitant use of hepatotoxic drugs	Headache and gastrointestinal upset
	Terbinafine: first line of treatment for dermatophyte onychomycosis, and generally preferred over itraconazole	Hepatic impairment, renal impairment	250 mg per day for 6 weeks in fingernail and 12–16 weeks in toenail infection	Headache, taste disturbance and gastrointestinal upset. Can aggravate psoriasis and cause a subacute lupus-like syndrome
		Hepatic impairment, renal impairment	Baseline liver function tests and a complete full blood count are recommended in adult patients with a history of hepatotoxicity or haematological abnormalities
B	Fluconazole: may be a useful alternative in patients unable to tolerate terbinafine or itraconazole	Hepatic impairment, renal impairment	150–450 mg per week for 3 months in fingernail infections and for at least 6 months in toenail infections	Headache and gastrointestinal upset
B		Hepatic impairment, renal impairment	Perform baseline liver function tests and full blood count. Monitor liver function tests in high-dose or prolonged therapy and in those at risk because of concomitant hepatotoxic drug use	Headache and gastrointestinal upset
C	Griseofulvin: lower efficacy and higher relapse rates compared with terbinafine and itraconazole	Liver impairment	500–1000 mg per day given for 6–9 months in fingernail infection and 12–18 months in toenail infection. It should be taken with fatty food to increase absorption	Headache and gastrointestinal upset
D	Combination treatment: recommended if response to topical monotherapy is likely to be poor
	Topicals
D	Amorolfine: useful for superficial and distal onychomycosis		5% lacquer applied once or twice a week for 6–12 months	Adverse effects are rare: local burning, pruritus and erythema
	Ciclopirox: useful for superficial and distal onychomycosis and for patients in whom systemic therapy is contraindicated		8% lacquer applied once daily for up to 48 weeks	Adverse effects are rare: periungual and nail fold erythema
	Tioconazole: useful for superficial and distal onychomycosis		28% solution applied twice daily for 6–12 months	Allergic contact dermatitis

Table 2. Summary of drug therapies in children (age 1–12 years)
Strength of recommendation	Treatment in children	Contraindications and cautions	Suggested method of use and monitoring	Common adverse reactions
A	Itraconazole: first line of treatment for dermatophyte onychomycosis	Heart failure, hepatotoxicity	'Pulse therapy' 5 mg kg⁻¹ per day for 1 week per month. Two pulses are recommended for fingernails and three pulses for toenails. It is optimally absorbed with food and an acidic pH	Headache and gastrointestinal upset
		Heart failure, hepatotoxicity	Monitoring hepatic function tests is recommended in patients with pre-existing deranged results, in those receiving continuous therapy for more than a month, and with concomitant use of hepatotoxic drugs	Headache and gastrointestinal upset
	Terbinafine: first line of treatment for dermatophyte onychomycosis and generally preferred over itraconazole	Hepatic impairment, renal impairment	62·5 mg per day if weight is < 20 kg, 125 mg per day for 20–40 kg weight, and 250 mg per day for > 40 kg, for 6 weeks in fingernail and 12 weeks in toenail infection	Headache, taste disturbance and gastrointestinal upset. Can aggravate psoriasis and cause a subacute lupus-like syndrome
		Hepatic impairment, renal impairment	Baseline liver function tests and a complete full blood count are recommended in paediatric patients as it is unlicensed for use in children
B	Fluconazole: consider as second line if itraconazole and terbinafine contraindicated or not tolerated	Hepatic impairment, renal impairment	3–6 mg kg⁻¹ once a week for 12–16 weeks for fingernail and 18–26 weeks for toenail infection	Headache and gastrointestinal upset
B		Hepatic impairment, renal impairment	Perform baseline liver function tests and full blood count. Monitor liver function tests in high-dose or prolonged therapy and in those at risk because of concomitant hepatotoxic drug use	Headache and gastrointestinal upset
C	Griseofulvin: consider as second line if itraconazole and terbinafine contraindicated or not tolerated	Liver impairment	10 mg kg⁻¹ per day for age groups of 1 month and above (maximum 500 mg)	Headache and gastrointestinal upset
C		Liver impairment	It should be taken with fatty food to increase absorption	Headache and gastrointestinal upset

Appendix 1. Levels of evidence
Level of evidence^a	Type of evidence
1++	High-quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias
1+	Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias
1−	Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias
2++	High-quality systematic reviews of case–control or cohort studies
2++	High-quality case–control or cohort studies with a very low risk of confounding, bias or chance and a high probability that the relationship is causal
2+	Well-conducted case–control or cohort studies with a low risk of confounding, bias or chance and a moderate probability that the relationship is causal
2−	Case–control or cohort studies with a high risk of confounding, bias or chance and a significant risk that the relationship is not causal
3	Nonanalytical studies (for example case reports, case series)
4	Expert opinion, formal consensus

RCT, randomized controlled trial. ^aStudies with a level of evidence '−' should not be used as a basis for making a recommendation.

Appendix 2. Strength of recommendation
Class	Evidence
A	At least one meta-analysis, systematic review or RCT rated as 1++, and directly applicable to the target population, or
	A systematic review of RCTs or a body of evidence consisting principally of studies rated as 1+, directly applicable to the target population and demonstrating overall consistency of results
	Evidence drawn from a NICE technology appraisal
B	A body of evidence including studies rated as 2++, directly applicable to the target population and demonstrating overall consistency of results, or
B	Extrapolated evidence from studies rated as 1++ or 1+
C	A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results, or
C	Extrapolated evidence from studies rated as 2++
D	Evidence level 3 or 4, or
	Extrapolated evidence from studies rated as 2+, or
	Formal consensus
D (GPP)	A good practice point (GPP) is a recommendation for best practice based on the experience of the guideline development group