Efficacy of 4 weeks topical bifonazole treatment for onychomycosis after nail ablation with 40% urea: a double‐blind, randomized, placebo‐controlled multicenter study

Abstract

Onychomycosis is a common fungal infection most often affecting the toenails. If untreated, it can cause discomfort sufficient to reduce quality of life. To evaluate efficacy and safety of bifonazole cream vs. placebo in onychomycosis treatment after non-surgical nail ablation with urea paste. Fifty-one study centres randomized 692 subjects with mild-to-moderate onychomycosis to receive bifonazole 1% cream or placebo for 4 weeks following non-surgical nail ablation with urea 40% paste over 2-4 weeks. Efficacy of the two phase treatment was evaluated by overall cure of the target nail comprising clinical and mycological cure 2 weeks, 3 and 6 months after end of treatment. At 2 weeks (primary endpoint), overall cure rate was superior in bifonazole-treated group (54.8% vs. 42.2% for placebo; P = 0.0024). The clinical cure rate was high in both treatment groups (86.6% bifonazole vs. 82.8% placebo), but proportion with mycological cure was higher with bifonazole treatment (64.5%) vs. placebo treatment 49.0%, (P = 0.0001). We observed higher early overall cure rate with 4 weeks topical bifonazole compared with placebo after removal of infected nail parts with urea. This two stage treatment was well tolerated and offers an additional option in topical onychomycosis therapy.

Onychomycosis: A Review

“…The poor nail unit penetration limits the use of topical antifungal agents, and relapses and re-infections are common, occurring in at least 20%–25% of patients [ 21 ]. A combination with systemic antifungals, debridement or nail avulsion in severe onychomycosis reduces the duration of treatment and increases the cure rate [ 22 ]. Nail lacquers are effective in monotherapy in the treatment of WSO and of DLSO limited to less than 50% of the distal nail [ 23 ].…”

Race reporting and representation in onychomycosis clinical trials: A systematic review

“…Of the 302 PubMed initial search results, 182 clinical trials (28,352 participants) met inclusion criteria and were included in the final analysis 6–186 . The PRISMA study selection process is detailed in Figure 1.…”

Patient‐reported outcomes from two randomised studies comparing once‐weekly application of amorolfine 5% nail lacquer to other methods of topical treatment in distal and lateral subungual onychomycosis

“…Incomplete nail debridement following daily application of urea ointment for 2-4 weeks is a determinant factor for efficacy and is therefore considered an exclusion criterion when studying the efficacy of bifonazole cream in onychomycosis. 31 Although urea ointments are available OTC, the success rate of home debridement, without the support of a health professional, remains largely unexplored. Based on the available evidence, home debridement with urea ointment may be challenging, with reported failure to completely debride the affected nail area after 3 weeks ranging between 40%-60%.…”

“…Incomplete nail debridement following daily application of urea ointment for 2‐4 weeks is a determinant factor for efficacy and is therefore considered an exclusion criterion when studying the efficacy of bifonazole cream in onychomycosis . Although urea ointments are available OTC, the success rate of home debridement, without the support of a health professional, remains largely unexplored.…”