Ciclopirox olamine cream or lotion is used topically for the treatment of certain dermatophytoses (i.e., tinea pedis, tinea cruris, tinea corporis) caused by Trichophyton mentagrophytes, T. rubrum, Epidermophyton floccosum, or Microsporum canis; for the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare or P. ovale); and for the treatment of cutaneous candidiasis (moniliasis) caused by Candida albicans. Ciclopirox gel is used topically for the treatment of tinea corporis and interdigital tinea pedis caused by T. rubrum, T. mentagrophytes, or E. floccosum and for the treatment of seborrheic dermatitis of the scalp. Ciclopirox shampoo is used topically for the treatment of seborrheic dermatitis of the scalp. Ciclopirox solution (nail lacquer) is used topically for the treatment of mild to moderate onychomycosis of fingernails and toenails, without lunula involvement, caused by T. rubrum in immunocompetent patients.
Dermatophytoses and Cutaneous Candidiasis
Ciclopirox olamine topical cream or lotion is used for the treatment of tinea corporis, tinea cruris, tinea pedis, and cutaneous candidiasis. The gel is used topically for the treatment of tinea corporis and tinea pedis. Tinea corporis and tinea cruris generally can be effectively treated using a topical antifungal; however, an oral antifungal may be necessary if the disease is extensive, dermatophyte folliculitis is present, the infection is chronic or does not respond to topical therapy, or the patient is immunocompromised or has coexisting disease. Many clinicians consider topical imidazole-derivative azole antifungals (e.g., clotrimazole, econazole, ketoconazole, miconazole, oxiconazole, sulconazole) or topical allylamine antifungals (e.g., naftifine, terbinafine) the drugs of first choice for the topical treatment of tinea corporis or tinea cruris, although other topical antifungal agents (e.g., ciclopirox olamine, butenafine hydrochloride, tolnafate, undecylenic acid) also can be effective in the treatment of these infections. While topical antifungals usually are effective for the treatment of uncomplicated tinea pedis, an oral antifungal usually is necessary for the treatment of hyperkeratotic areas on the palms and soles, for chronic moccasin-type (dry-type) tinea pedis, and for the treatment of tinea unguium (onychomycosis).
Clinical studies to date indicate that ciclopirox olamine 0.77% (expressed in terms of the base) cream or lotion is effective for the topical treatment of dermatophytoses and appears to be similar in efficacy and safety to topical clotrimazole 1% cream. Some studies reported by the manufacturer suggest a slight advantage over topical clotrimazole 1% cream for the treatment of tinea pedis or cutaneous candidiasis, but additional controlled, comparative studies are needed to establish the relative efficacy of ciclopirox olamine and other currently available topical antifungal agents. Like imidazole derivatives (e.g., clotrimazole, econazole, ketoconazole, miconazole, sulconazole), ciclopirox olamine has an advantage over some other topical antifungal agents (e.g., nystatin, tolnaftate) in the treatment of mixed infections or for empiric treatment pending identification of the causative organism since the drug is active against both dermatophytes and Candida.
Pityriasis (Tinea) Versicolor
Ciclopirox olamine topical cream or lotion is used for the treatment of pityriasis (tinea) versicolor, a superficial infection caused by Malassezia furfur (Pityrosporum orbiculare or P. ovale). Pityriasis (tinea) versicolor generally can be treated topically with an imidazole-derivative azole antifungal (e.g., clotrimazole, econazole, ketoconazole, miconazole, oxiconazole, sulconazole), an allylamine antifungal (e.g., terbinafine), ciclopirox olamine, or certain other topical therapies (e.g., selenium sulfide 2.5%). However, an oral antifungal (e.g., itraconazole, ketoconazole) may be indicated, with or without a topical agent, in patients who have extensive or severe infections or who fail to respond to or have frequent relapses with topical therapy.
Ciclopirox gel or shampoo is used topically for the treatment of seborrheic dermatitis of the scalp. Efficacy of ciclopirox gel has not been studied in immunocompromised individuals or in patients with acne-, atopic dermatitis-, parkinsonian syndrome-, psoriasis-, or rosacea-associated seborrheic dermatitis. There is no clinical experience to date with use of ciclopirox shampoo in immunocompromised individuals such as those with extensive, persistent, or unusual distribution of dermatomycoses; recent or recurrent herpes zoster or persistent herpes simplex; human immunodeficiency virus (HIV) infection; transplantation; or diabetic neuropathy.
Efficacy of ciclopirox shampoo for the treatment of seborrheic dermatitis of the scalp has been established in 2 randomized, double-blind clinical studies of 4 weeks' duration in patients 16 years of age or older. Patients in these studies were evaluated at week 4 on the overall status of the seborrheic dermatitis, the presence and severity of erythema or inflammation, and scaling, using a scale of 0 (none) to 5 (severe). In these 2 studies, 26-58% of patients receiving ciclopirox shampoo twice weekly simultaneously achieved scores of 0 (or a score of 1 if the baseline score was 3 or greater) for status of the seborrheic dermatitis, erythema or inflammation, and scaling compared with 13-31% of those receiving vehicle twice weekly. These 2 studies did not include sufficient numbers of black patients to determine whether they respond differently to ciclopirox shampoo than patients of other races.
The management of onychomycosis may include no therapy, palliative treatment with mechanical or chemical debridement, oral and/or topical antifungal therapy, or a combination of several of these therapies. Many clinicians consider oral antifungals (e.g., itraconazole, terbinafine) first-line drugs for the management of onychomycosis of toenails because of their greater efficacy compared with that of topical antifungals. However, oral antifungals may be associated with potentially serious adverse systemic effects in some patients. Topical antifungals (e.g., ciclopirox solution, amorolfine solution [currently not commercially available in the US], bifonazole cream or ointment [currently not commercially available in the US]) usually do not cause serious adverse systemic effects; however, their relative efficacy is low. Response rate to topical antifungal therapy is dependent on the type and extent of infection. Failure to respond to topical antifungals is more likely to occur in patients with 5 or more infected toenails, infections involving more than 30-50% of the nail plate, and in those with thickly keratinized, dystrophic, already damaged nails. In cases of minor nail involvement (less than 30% of nail plate in distal subungual onychomycosis) topical therapy may be useful; however, oral therapy usually is preferred in patients with more extensive involvement.
Although there are no studies evaluating the concomitant use of oral antifungals with topical antifungals (i.e., ciclopirox topical solution [nail lacquer]), some clinicians suggest that such use may be beneficial in the management of onychomycosis since the topical solutions may quickly reach nail plate areas that are not touching the nail bed while oral agents may affect the nail bed and proximal areas. In addition, because, in some patients, therapy-resistant onychomycosis may be associated with the presence of persistent fungi packets in both the infected nail beds and nail plates, concomitant oral and topical therapy may be useful in such patients.
Use of Ciclopirox in Onychomycosis
Ciclopirox topical solution (Penlac nail lacquer) is used as a component of a comprehensive management program (e.g., monthly removal of unattached, infected nail(s) by a qualified clinician experienced in nail disorders) in the treatment of mild-to-moderate onychomycosis of fingernails and toenails, without lunula involvement, caused by T. rubrum, in immunocompetent patients. Efficacy and safety of ciclopirox topical solution (nail lacquer) have not been studied in immunocompromised individuals such as those with extensive, persistent, or unusual distribution of dermatomycoses; extensive seborrheic dermatitis; severe plantar/moccasin-type tinea pedis, recent or recurrent herpes zoster or persistent herpes simplex, HIV infection; solid organ transplantation, insulin-dependent diabetes, or diabetic neuropathy; and those with seizures requiring anticonvulsants.
Ciclopirox topical solution (nail lacquer) received FDA approval for onychomycosis based on 2 double-blind, placebo-controlled studies. Efficacy of ciclopirox topical solution (nail lacquer) has been established in patients with toenail onychomycosis. Patients were assessed for ''complete cure'' (mycologic and clinical [clear nail] cure), ''almost clear'' (mycologic cure and 10% or less nail involvement), and ''negative mycology alone'' (mycologic cure only). In these toenail studies, up to 48 weeks of continuous therapy with topical 8% ciclopirox topical solution (nail lacquer) (applied once daily in conjunction with monthly removal of unattached, infected toenail[s] by the clinical investigators) was more effective than placebo. In these studies, 5.5-8.5 or 0-0.9% of patients experienced ''complete cure'' receiving the drug or placebo, respectively, 6.5-12 or 0.9% experienced ''almost clear'' cure receiving the drug or placebo, respectively, and 29-36 or 9- 11% experienced a ''mycologic cure alone'' receiving the drug or placebo, respectively, when evaluated 48 weeks after initiating therapy. However, only 58% of those experiencing ''complete cure'' were still free of the infection 12 weeks after completion of therapy.
Although comparative data are lacking, oral antifungal agents (e.g., itraconazole, terbinafine) reportedly have greater efficacy in the treatment of onychomycosis of the toenails than topical antifungals (e.g., ciclopirox topical solution). Results of several placebo-controlled studies indicate that 14-38% of patients receiving 12 weeks of continuous therapy with oral itraconazole or terbinafine experienced both mycologic and clinical cure, while only 5.5-8.5% of patients receiving topical ciclopirox solution (nail lacquer) experienced ''complete cure'' (mycologic and clinical [clear nail] cure).
Some clinicians state that in patients with onychomycosis, combined use of an oral antifungal agent with a topical antifungal (e.g., ciclopirox solution) may result in improved efficacy relative to the use of an oral antifungal agent alone; however, further studies are needed to determine whether such combined therapy will be a feasible option in terms of efficacy, adverse effects profile, and cost. The manufacturer of ciclopirox topical solution (Penlac [nail lacquer]) states that since no studies have been conducted in patients with onychomycosis to determine whether topical ciclopirox solution might reduce efficacy of systemic antifungals, combined use of the topical solution with a systemic antifungal agent for the management of this condition currently is not recommended.
Ciclopirox olamine has been used with some success as a vaginal cream for the treatment of vulvovaginal candidiasis. The vaginal cream currently is not commercially available in the US.