Definitions for the grades of the evidence (I, II-1, II-2, II-3, III) and the strength of the recommendations (A-E) are repeated at the end of the Major Recommendations field.
- Complete a comprehensive history of presenting symptoms with particular attention to history of onset, duration, morphology of nail, predisposing factors, and prior treatments and outcomes.
- The physical examination should include the degree of severity: nail color, texture, nail base angle, plate firmness and adherence to the nail bed. In addition, examine the nail for ridging, beading, pitting, peeling/crumbling, and presence of odor. Severe onychomycosis is defined as >80% of nail surface and/or matrix involvement of at least one toenail (excluding the fifth metatarsal).
- Diagnostic tests indicated for diagnosis of onychomycosis include microscopy, Wood's lamp examination, skin/nail biopsy, and fungal culture (if considering long term oral therapy). Differential diagnoses include lichen planus, psoriasis, myxoid cyst, yellow nail syndrome, peripheral vascular disease, and trauma.
- Lifestyle modifications may aid in the prevention of onychomycosis. Modifications consist of wearing properly fitting shoes, using shower shoes in community showers, washing feet daily with soap and water, wearing hosiery made of synthetic materials, and supplying manicurist with personal pedicure/manicure tools (strength of recommendation B; quality of evidence III).
- 5% amorolfine (Loceryl)* applied once weekly for 15 months in combination with terbinafine (Lamasil) 250mg orally every day for 12 weeks is strongly supported as the most effective means of mycological and clinical cure for severe dermatophyte onychomycosis. In addition, studies indicate combination therapy to be the most cost-effective means of treatment as compared to monotherapy. (strength of recommendation A; quality of evidence I).
- 5% amorolfine (Loceryl) applied once weekly for 24 weeks in combination with itraconazole (Sporanox) 200mg orally every day for 12 weeks is strongly supported as the most effective means of mycological and clinical cure for severe non-dermatophyte onychomycosis. This combination was also shown to be a more cost-effective treatment as compared to monotherapy. (strength of recommendation A; quality of evidence I).
- Multiple randomized, controlled studies support the use of nail lacquers for effective treatment of mild to moderate onychomycosis. 5% amorolfine (Loceryl) applied once or twice weekly for six months for fingernails and nine to twelve months for toenails (strength of recommendation A; quality of evidence I) or 8% ciclopirox (Penlac) applied daily for 48 weeks with monthly clinical removal of unattached nail (strength of recommendation A; quality of evidence I).
- Respected authorities recommend 40% Urea (Carmol 40), 40% Urea Keratolytic topical solution applied 1 to 2 times a day until complete chemical avulsion of nail is achieved. Indicated for moderate to severe nail involvement. Recommended for persons >18 years of age (strength of recommendation C; quality of evidence III). There is evidence to support the use of Carmol 40 as a preparatory agent to avulse the nail and leave the nail bed more permeable to treatment with a topical antifungal (strength of recommendation B, quality of evidence I).
- Oral antifungals as monotherapy have been strongly supported for the treatment of moderate to severe onychomycosis. Terbinafine (Lamasil) 250mg orally every day for 6 weeks for fingernails and 12 to 16 weeks for toenails has been shown to be the most effective treatment of dermatophyte infection (strength of recommendation A; quality of evidence I). Itraconazole (Sporanox) 200mg orally every day for 12 weeks or pulse therapy (400mg PO qd x one week q four weeks for 12-16 weeks) has been shown to be the most effective treatment of non-dermatophyte infection, with greater efficacy in favor of pulse therapy (strength of recommendation A; quality of evidence I). Fluconazole (Diflucan) 150mg once weekly for 24 weeks demonstrated lower efficacy in clinical and mycological cure of non-dermatophyte infections (strength of recommendation A; quality of evidence I).
- Complete blood count and liver function tests should be monitored prior to, during, and at the end of treatment with oral antifungals. When using nail lacquer treatment, nails should be cut and filed monthly by a healthcare professional.
- Referral should be made to a podiatrist for severe and relapsing cases.
* 5% amorolfine (Loceryl) is not available in the United States at this time.
Definitions:
Strength of Recommendation
- There is good evidence to support the recommendation that the treatment be specifically considered in the management of onychomycosis.
- There is fair evidence to support the recommendation that the treatment be specifically considered in the management of onychomycosis.
- There is insufficient evidence to recommend for or against the inclusion of the treatment in the management of onychomycosis, but recommendations may be made on other grounds.
- There is fair evidence to support the recommendation that the treatment be excluded from consideration in the management of onychomycosis.
- There is good evidence to support the recommendation that the treatment be excluded from consideration in the management of onychomycosis.
Quality of Evidence
I. Evidence obtained from at least one properly randomized controlled trial.
II-1. Evidence obtained from well-designed controlled trials without randomization.
II-2. Evidence obtained from well-designed cohort or case-controlled analytic studies, preferably from more than one center or research group.
II-3. Evidence obtained from multiple time series with or without intervention. Dramatic results in uncontrolled experiments (such as the results of the introduction of penicillin treatment in the 1940s) could be regarded as this type of evidence.
III. Opinions of respected authorities based on clinical experience descriptive studies and case reports or reports of expert committees.
Adapted from: U.S. DHHS, Office of Public Health & Science. U.S. Preventive Services Task Force, (1996). Guideline to Clinical Preventive Services, (2nd ed.), Alexandria, VA: International Medical Publishing, Inc.
