Bifonazole Cream in the Treatment of Superficial Candidosis

Abstract

This is the summary of a prospective, randomized, double-blind study comparing four therapeutic regimens: bifonazole cream applied once or twice daily, clotrimazole and placebo twice daily during 4 weeks for the treatment of cutaneous candidosis. The study is multicentric and was accomplished in four centres of different climate: Costa Rica, Dominican Republic, Sweden and Yugoslavia. The trial was carried out with approximately identical numbers of patients: 275 in total. The duration of treatment was 4 weeks and the check-ups were done before, during and 2 weeks after the end of the therapy. The results have shown the great efficacy of bifonazole cream (65–75%) in comparison to placebo (19.4%). There was no significant difference in applying bifonazole cream once or twice daily. So the reasonable therapy with bifonazole as to apply it only once a day, is confirmed. The excellent tolerance and absence of side-effects in such an extended study have once more proved the value of this antimycotic in topical treatment of cutaneous candidosis.

Cutaneous candidiasis – an evidence‐based review of topical and systemic treatments to inform clinical practice

“…Clotrimazole, nystatin and miconazole are the most studied topical drugs demonstrating similar efficacy with complete clinical and mycological cure rates of 73%–100%. In head‐to‐head studies against one of these drugs, similar clinically and/or mycologically effects were observed with amphotericin B, ciclopirox, sulconazole, haloprogin, bifonazole, flucytosine and mupirocin . In addition, oxiconazole, eberconazole, bifonazole and sertaconazole demonstrated high complete cure rates of at least 90%, yet, neither of the drugs have been tested against clotrimazole, nystatin or miconazole for cutaneous candidiasis.…”

“…In infants, clinical cure was obtained at the latest at day 7. In children above the age of five, adults or unspecified populations, clinical cure rates alone ranged from 44% to 100%, mycological cure rates from 78% to 100% and complete cure (clinically as well as mycologically) from 73% to 100%, which was significantly higher than placebo (complete cure rates of 0%–52% ( P < 0.01) . Clotrimazole also seemed superior to eberconazole with complete cure rates of 73% vs. 50% (no comparisons) .…”

“…Overall, 41 articles investigated topical therapy for cutaneous candidiasis including 2711 patients in 35 RCTs (LE: 1B) and seven prospective blinded or open‐label trials (LE: 2B), of which one article reported two trials in the same article (LE: 1B and 2B) (Table ). In total, 17 different single‐drug and four combination therapies were investigated including clotrimazole (12 studies, LE: 1B or 2B), nystatin (ten studies, LE: 1B or 2B), miconazole (eight studies, LE: 1B), halcinonide–neomycin–amphotericin B (three studies, LE: 1B), ciclopirox (two studies, LE: 1B and 2B), haloprogin (two studies, LE: 1B), halcinonide–neomycin–nystatin (two studies, LE: 1B), naftifine (two studies, LE: 1B), sulconazole (two studies, LE: 1B), mupirocin (two studies, LE: 1B or 2B) and a number of drugs tested in a single study (Table ). In 50% of the studies, the type of Candida was specified by microscopy and/or culture and the majority recorded C. albicans , whereas three studies also found a few patients with C. parapsilosis or C. tropicalis .…”

“…Topical clotrimazole 1% twice daily for 2–12 weeks was tested in 12 studies including all body sites in adults and children above the age of five, infants with diaper dermatitis and uncharacterized study populations, respectively (Table ). In infants, clinical cure was obtained at the latest at day 7.…”

“…Comparisons with sulconazole were inconclusive (Table ) . Clotrimazole was comparable to bifonazole 1% twice daily ( P = 0.195), miconazole 2% twice daily (complete cure in both groups), nystatin 100 000 U/g twice daily [complete cure/clinical cure in 55% vs. 58%/microscopy and culture cure in 92% vs 92% (no P ‐values)] and systemic fluconazole 150 mg once weekly (complete clinical cure in both groups and mycological cure in 71% vs 100%, non‐significant) . No studies reported therapies superior to clotrimazole.…”