Topical treatments for fungal infections of the skin and nails of the foot.
Fungal infections of the feet normally occur in the outermost layer of the skin (epidermis). The skin between the toes is a frequent site of infection which can cause pain and itchiness. Fungal infections of the nail (onychomycosis) can affect the entire nail plate.
To assess the effects of topical treatments in successfully treating (rate of treatment failure) fungal infections of the skin of the feet and toenails and in preventing recurrence.
We searched the Cochrane Skin Group Specialised Register (January 2005), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 1, 2005), MEDLINE and EMBASE (from inception to January 2005). We screened the Science Citation Index, BIOSIS, CAB ‐ Health and Healthstar, CINAHL DARE, NHS Economic Evaluation Database and EconLit (March 2005). Bibliographies were searched.
Randomised controlled trials (RCTs) using participants who had mycologically diagnosed fungal infections of the skin and nails of the foot.
Data collection and analysis
Two authors independently summarised the included trials and appraised their quality of reporting using a structured data extraction tool.
Of the 144 identified papers, 67 trials met the inclusion criteria. Placebo‐controlled trials yielded the following pooled risk ratios (RR) of treatment failure for skin infections: allylamines RR 0.33 (95% CI 0.24 to 0.44); azoles RR 0.30 (95% CI 0.20 to 0.45); ciclopiroxolamine RR 0.27 (95% CI 0.11 to 0.66); tolnaftate RR 0.19 (95% CI 0.08 to 0.44); butenafine RR 0.33 (95% CI 0.24 to 0.45); undecanoates RR 0.29 (95% CI 0.12 to 0.70). Meta‐analysis of 11 trials comparing allylamines and azoles showed a risk ratio of treatment failure RR 0.63 (95% CI 0.42 to 0.94) in favour of allylamines. Evidence for the management of topical treatments for infections of the toenails is sparser. There is some evidence that ciclopiroxolamine and butenafine are both effective but they both need to be applied daily for prolonged periods (at least one year). The six trials of nail infections provided evidence that topical ciclopiroxolamine has poor cure rates and that amorolfine might be substantially more effective but more research is required.
Placebo‐controlled trials of allylamines and azoles for athlete's foot consistently produce much higher percentages of cure than placebo. Allylamines cure slightly more infections than azoles and are now available OTC. Further research into the effectiveness of antifungal agents for nail infections is required.
Fay Crawford, Sally Hollis
Plain language summary
Creams, lotions and gels (topical treatments) for fungal infections of the skin and nails of the foot
We found lots of evidence to show fungal skin infections of the skin of the feet (athlete's foot or tinea pedis) are effectively managed by over the counter topical antifungal creams, lotions and gels. The most effective topical agent was terbinafine. Other topical agents such as azoles, ciclopiroxolamine, butenafine, tolnaftate and undecanoate were also effective in curing athlete's foot.
Evidence for the management of topical treatments for management of dermatophyte infections of the toenails was sparser and the studies are small. There was some evidence that ciclopiroxolamine and butenafine are both effective but they both needed to be applied daily for prolonged periods (at least one year).
Fay Crawford, Sally Hollis
Implications for practice
All antifungal compounds demonstrated some success in curing athlete's foot. The best results were observed with the use of allylamines and there is a small amount of evidence that butenafine may be similarly good. Azoles are also very effective and participants should be advised that although all azoles appear to be similarly effective, using an azole cream for four weeks is likely to produce better results than using it for one week. Azoles may also be more efficacious than tolnaftate but they seem no more efficacious than undecanoic acid. There is limited evidence about the efficacy of tea tree oil for skin infections.
There is little evidence that topical anti‐fungals are effective in the management of onychomycosis or fungally infected toe nails. The majority of available data demonstrate low cure rates after long treatment times with ciclopiroxolamine. Amorolfine and butenafine may be much more effective than ciclopiroxolamine and tea tree oil but only a few observations are available.
Implications for research
The estimates of effectiveness of allylamines and azoles relative to placebo have conclusively demonstrated these drugs to be of greater effectiveness and we recommend that no more placebo controlled trials of allylamines or azoles should be conducted.
More direct comparisons of undecanoic acid and tolnaftate with allylamines and azoles for athlete's foot are required. Large randomised controlled trials comparing the effectiveness of topical amorolfine and butenafine are needed to establish an alternative to oral treatments for toe nail infections.