What is the treatment for onychomycosis using Penlac (ciclopirox)?

Treatment of Onychomycosis with Penlac (Ciclopirox)

Ciclopirox 8% nail lacquer (Penlac) is indicated as a topical treatment for mild to moderate onychomycosis of fingernails and toenails without lunula involvement, and should be used as part of a comprehensive management program that includes monthly removal of unattached, infected nails by a healthcare professional. 1

Indications and Positioning in Treatment Algorithm

Ciclopirox 8% nail lacquer is specifically appropriate for:

• Mild cases of onychomycosis with distal infection
• Superficial white onychomycosis (SWO)
• Cases where systemic therapy is contraindicated 2

The British Association of Dermatologists guidelines classify ciclopirox as useful for superficial and distal onychomycosis with a recommendation strength of C. 2

Application Method and Duration

• Apply ciclopirox 8% nail lacquer once daily for up to 48 weeks 2, 1
• Cover the entire nail plate and approximately 5mm of surrounding skin 1
• Remove the lacquer weekly using acetone 3
• The nail lacquer should be part of a comprehensive management program that includes removal of unattached, infected nails as frequently as monthly by a healthcare professional 1

Efficacy

Ciclopirox nail lacquer has modest efficacy:

• Mycological cure rates range from 29-36% compared to 9-11% with vehicle in US studies 4
• Higher mycological cure rates (46.7-85.7%) have been reported in non-US studies 4
• In an open non-comparative study, 36% of patients showed good improvement to complete cure after 9 months of treatment 3

Limitations

• Limited penetration through the nail plate
• Lower efficacy compared to oral antifungal agents
• Treatment duration is lengthy (up to 48 weeks)
• Not suitable for severe infections or those with lunula involvement 1
• Not studied in immunosuppressed patients, pregnant/nursing women, HIV-positive individuals, organ transplant recipients, epileptic patients, or insulin-dependent diabetics 1

Combination Therapy

Combination therapy with oral antifungals may improve outcomes:

• Mycological cure rates of 88.2% were observed with combined terbinafine and ciclopirox compared to 64.7% with terbinafine alone 5
• Ciclopirox can be an important adjunct to oral therapy in certain presentations (lateral onychomycosis, longitudinal spike, dermatophytoma, extensive onycholysis) 6
• However, concomitant use with systemic antifungals is not officially recommended in the FDA labeling 1

Alternative Topical Options

Other topical options for similar indications include:

• Amorolfine 5% lacquer: applied once or twice weekly for 6-12 months 2
• Tioconazole 28% solution: applied twice daily for 6-12 months 2

When to Consider Systemic Therapy Instead

Systemic therapy should be considered for:

• Moderate to severe onychomycosis
• Infections involving the lunula
• Cases where topical therapy has failed

First-line systemic options include:

• Terbinafine: 250mg daily for 6 weeks (fingernails) or 12 weeks (toenails) 2, 7
• Itraconazole: pulse therapy of 200mg twice daily for 1 week per month (2 pulses for fingernails, 3 pulses for toenails) 2, 7

Adverse Effects

Ciclopirox nail lacquer is generally well-tolerated:

• Adverse effects are rare
• May include periungual and nail fold erythema 2
• Most treatment-emergent adverse effects are transient and localized to the application site 4

Monitoring and Follow-up

• Regular follow-up to assess clinical response
• Consider mycological testing to confirm cure
• If no improvement after 24 weeks, reassess diagnosis and treatment approach

Ciclopirox nail lacquer provides a treatment option with a favorable benefit-to-risk ratio for patients with mild to moderate onychomycosis, particularly when systemic therapy is contraindicated or not preferred by the patient.