Efficacy and safety of topical terbinafine 10% solution (MOB-015) in the treatment of mild to moderate distal subungual onychomycosis: A randomized, multicenter, double-blind, vehicle-controlled phase 3 study.

BACKGROUND: Onychomycosis is a recalcitrant fungal nail infection. Topical antifungal agents may be preferred over systemic agents due to lack of systemic adverse effects. OBJECTIVE: To investigate the efficacy and safety of topical terbinafine 10% solution (MOB-015) for the treatment of distal and lateral subungual onychomycosis. METHODS: In a multicenter, double-blind, phase III, North American study, patients with mild to moderate distal and lateral subungual onychomycosis involving 20% to 60% of at least 1 great toenail were randomized to once daily application of MOB-015 or matching vehicle for 48 weeks. The primary efficacy variable was complete cure, while the secondary efficacy variables were mycological cure and treatment success. Safety evaluations were also performed. RESULTS: At week 52, the mycological cure (negative culture and potassium hydroxide microscopy) rate in the MOB-015 and vehicle groups was 69.9% and 27.7%, respectively (P < .001), and complete cure (0% clinical disease involvement and mycological cure) was achieved in 4.5% and 0% of patients, respectively (P = .0195). At least 1 adverse event leading to discontinuation of treatment occurred in 2.8% of patients in the MOB-015 group and in 4.2% in the vehicle group. LIMITATION: The follow-up period after end of treatment may not be sufficient to accurately reflect cure in distal and lateral subungual onychomycosis. CONCLUSIONS: MOB-015 is a treatment option for onychomycosis with an adverse event profile similar to vehicle.

Healing of chronic foot ulcers in diabetic patients treated with a human fibroblast-derived dermis.

A prospective, multicenter, randomized, controlled 12-week study was undertaken to evaluate the effectiveness of a human fibroblast-derived dermis for treating foot ulcers in the diabetic patient. This report summarizes the findings from one center. Following a 2-week screening period, patients were randomized to either human fibroblast-derived dermis (HFDD) (Dermagraft) plus saline-moistened gauze or to the control group (CT) of saline-moistened gauze alone. Effectiveness end points were: 1) wound closure by week 12, 2) time to wound closure, and 3) percent wound closure by week 12. Safety was assessed by review of adverse events and laboratory findings. Patients randomized to HFDD received an application at day 0 and up to seven additional treatments. All patients in each group received shoes with custom-molded inserts and were seen weekly. The study population was comprised of 28 patients (14 HFDD/14 CT) with chronic ulcers (>6 weeks' duration at time of screening). By week 12, significantly more chronic ulcers healed in the HFDD group than in the CT group (71.4% versus 14.3%, p = .003). Healed HFDD patients achieved wound closure significantly faster than CT patients (p = .004). Patients treated with HFDD showed a statistically significant higher percent of wound closure by week 12 than did CT patients (p = .002). The percent of patients who experienced an infection involving their study wound was less in the HFDD group than in the CT group. It was concluded that HFDD is a safe and effective treatment for chronic foot ulcers in diabetic patients.