What is Ciclopirox (antifungal medication)?

From the Guidelines

Ciclopirox is recommended as a treatment option for onychomycosis, particularly for toenail infections, with a recommended duration of treatment of up to 48 weeks. The medication is a hydroxypyridone derivative with broad-spectrum antifungal activity against various fungal species, including T. rubrum, S. brevicaulis and Candida species 1. It works by inhibiting metal-dependent enzymatic processes, including nutrient uptake, cellular energy production, and degradation of toxic intracellular peroxide.

Key Points to Consider

• Ciclopirox is available as an 8% lacquer applied once daily for up to 48 weeks.
• The medication has been shown to be more effective than placebo in the treatment of toenail onychomycosis, with a mycological cure rate of 34% and a clinical cure rate of 8% 1.
• Common side effects include periungual and nail fold erythema.
• There are no head-to-head trials comparing amorolfine with ciclopirox in the treatment of onychomycosis; however, cure rates are usually lower with ciclopirox 1.

Treatment Duration and Application

• The recommended duration of treatment is up to 24 weeks on the fingernails and up to 48 weeks on the toenails.
• Ciclopirox 8% nail lacquer should be applied daily to affected nails, with removal using alcohol once weekly before reapplication.

Important Considerations

• It is essential to complete the full treatment course even if symptoms improve earlier to prevent recurrence of the infection.
• Ciclopirox is generally well-tolerated but should not be used by individuals with known hypersensitivity to the medication.

From the FDA Drug Label

Ciclopirox Topical Solution, 8%, (Nail Lacquer), as a component of a comprehensive management program, is indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum

• The indications for Ciclopirox are for the treatment of mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum.
• The comprehensive management program includes removal of the unattached, infected nails as frequently as monthly, by a health care professional who has special competence in the diagnosis and treatment of nail disorders, including minor nail procedures.
• Concomitant use of 8% ciclopirox topical solution and systemic antifungal agents for onychomycosis is not recommended, as no studies have been conducted to determine whether ciclopirox might reduce the effectiveness of systemic antifungal agents for onychomycosis 2

From the Research

Mechanism of Action

• Ciclopirox has a unique mechanism of action, different from other topical antifungal drugs, which generally act through ergosterol inhibition 3.
• The high affinity of ciclopirox for trivalent metal cations results in inhibition of the metal-dependent enzymes responsible for the degradation of peroxides within the fungal cell 3, 4.
• This mechanism of action provides a very low potential for the development of resistance in pathogenic fungi, with cases of resistance rarely reported 3.

Antimicrobial Profile

• Ciclopirox has a broad antimicrobial profile, including nearly all clinically relevant dermatophytes, yeasts, and moulds 3.
• It is also active against certain frequently azole-resistant Candida species and against some bacteria 3.
• The lotion and cream formulations of ciclopirox are effective in many types of infection, including tinea corporis/cruris, tinea pedis, cutaneous candidiasis, pityriasis (tinea) versicolor, and seborrheic dermatitis 5.

Clinical Uses

• Ciclopirox is indicated for the treatment of fungal skin infections and vaginal candidiasis 3.
• It has also been clinically investigated in seborrhoeic dermatitis and onychomycosis, showing good efficacy and excellent tolerability 3.
• The ciclopirox medicated nail lacquer has been found to have superior efficacy and safety to another commercially available formulation in the treatment of onychomycosis 3.

Safety and Tolerability

• Ciclopirox is devoid of systemic adverse reactions 3.
• Mild local reactions, characterized by a burning sensation of the skin, irritation, redness, pain, or pruritus, can be observed following skin and vaginal application, generally in less than 5% of treated patients 3.
• With nail application, the most common adverse event is the appearance of mild erythema in 5% of the treated population 3.