Ketoconazole 2% Cream is NOT Recommended for Onychomycosis
Ketoconazole 2% cream should not be used as a treatment for onychomycosis, as topical therapy is only appropriate for superficial white onychomycosis or very early distal lateral subungual onychomycosis, and even then, ketoconazole cream is not among the recommended topical agents. 1, 2
Why Ketoconazole 2% Cream Fails
Guideline-Based Recommendations
British Association of Dermatologists (2014) does not list ketoconazole cream among recommended topical treatments for onychomycosis, instead recommending amorolfine nail lacquer as the topical agent of choice when topical therapy is indicated 1
Systemic therapy is almost always more successful than topical treatment, which should only be used in superficial white onychomycosis, possibly very early distal lateral subungual onychomycosis, or when systemic therapy is contraindicated 1
The only topical preparations with evidence for onychomycosis are amorolfine 5% nail lacquer (approximately 50% cure rate) and tioconazole nail solution (20-70% cure rate), not ketoconazole cream 1
Clinical Evidence Against Ketoconazole Cream
A randomized controlled trial specifically evaluated nail avulsion followed by ketoconazole 2% cream and found only 43% mycological cure without occlusion and 67% with occlusion - results the authors concluded were "not very encouraging" and stated this approach "cannot be generally recommended" 3
Even when combined with surgical nail avulsion, total dystrophic onychomycosis showed the poorest response to ketoconazole cream, with all cases failing to respond 3
While a novel ketoconazole lacquer formulation (not the standard 2% cream) showed promise in laboratory studies for transungual delivery, this is not the commercially available cream formulation 4
What Should Be Used Instead
First-Line Treatment
Oral terbinafine 250 mg daily for 12 weeks is the first-line treatment for dermatophyte toenail onychomycosis due to superior efficacy, fungicidal properties, and favorable cost-effectiveness 5, 2
Oral itraconazole 200 mg daily for 12 weeks continuously (or pulse dosing: 200 mg twice daily for 1 week per month for 3 pulses) is an alternative first-line option 1, 2
When Topical Therapy Is Appropriate
Amorolfine 5% nail lacquer is the recommended topical agent when infection is limited to the distal portion of the nail and systemic therapy is contraindicated 1, 2
Topical therapy should only be considered for superficial white onychomycosis or very early distal lateral subungual onychomycosis with less than 80% nail plate involvement and no lunula involvement 5, 2
Critical Pitfalls to Avoid
Do not use ketoconazole cream alone - it lacks sufficient nail penetration and is not formulated for transungual delivery 3
Do not expect rapid results - complete nail regrowth may take up to 18 months due to slow toenail growth patterns 1, 5
Do not use oral ketoconazole for dermatophyte onychomycosis due to hepatotoxicity concerns; it may only be considered for recalcitrant yeast infections 1
Address recurrence risk factors including wearing protective footwear, using antifungal powders in shoes, keeping nails short, and treating all infected family members simultaneously 1, 2