Treatment of distal subungual onychomycosis with a topical preparation of urea, propylene glycol and lactic acid: results of a 24-week, double-blind, placebo-controlled study.

Onychomycosis is difficult to cure as this requires eradication of the primary infection and protection of new areas of growth from reinfection. A new topical treatment (K101) has been developed. The aim of this study was to assess the efficacy, safety and tolerability of K101 treatment of distal subungual onychomycosis. This was a 24-week (plus 2-week washout), multicentre, randomised, double-blind, placebo-controlled study in 493 patients with distal subungual onychomycosis (K101, n = 346; placebo, n = 147), stratified according to degree of nail involvement. More patients with ≤50% nail involvement achieved the primary endpoint (mycological cure after 26 weeks) in the K101 group (27.2%) than placebo (10.4%; P = 0.0012). Proportions for patients with 51-75% involvement were 19.1% for K101 and 7.0% for placebo (not significant). More patients applying K101 than placebo judged that their condition had improved from week 2 (P = 0.0148) to week 24 (P = 0.0004). No safety issues were identified. K101 provides early visible improvements in nail appearance and a clinically meaningful antifungal activity.

Diagnosis of prostate cancer: optimal number of prostate biopsies related to serum prostate-specific antigen and findings on digital rectal examination.

The optimal number of core biopsies of the prostate that are needed for the detection of prostate cancer is unknown. A retrospective review of protocols and charts concerning 1149 transrectal ultrasound examinations with biopsy performed in 1013 patients was undertaken. Cancer detection rate was correlated to findings on digital rectal examination (DRE), serum levels of prostate-specific antigen (PSA) and number of biopsies taken. The cancer detection rate was significantly higher in patients who had five or more cores taken compared to those who had four or less (49% versus 35%, p < 0.05) in patients with serum PSA less than 10 ng/ml and a DRE suspicious of malignancy. The same trend was seen in patients with normal DRE and PSA less than 10 ng/ml (14% versus 8%, p = 0.057), while the detection rate for prostate cancer was unaffected by the number of cores taken if serum PSA was above 10 ng/ml.