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.

The effect of K101 Nail Solution on Trichophyton rubrum and Candida albicans growth and ultrastructure.

K101 Nail Solution (trademarks Emtrix(®), Nalox(™), Naloc(™)) is a combination of propylene glycol, urea and lactic acid in a topical formulation for the treatment of nails affected by onychomycosis. The aim of this study was to investigate the Minimal Cidal Concentration (MCC) of K101 Nail Solution against Trichophyton rubrum and Candida albicans as well as the effect of K101 Nail Solution on the micromorphology of these fungi. The MCC of K101 Nail Solution against T. rubrum and C. albicans was 50% after 60-min exposure time. A MCC of 50% for K101 Nail Solution means that K101 Nail Solution diluted with e.g. water to 50% will totally kill the fungi tested. In the scanning electron microscope C. albicans cells, treated with 50% K101 Nail Solution, showed a shrunken surface. T. rubrum cells were severely damaged shown as collapse and degradation of the cells. In the transmission electron microscope most C. albicans cells, treated with 50% K101 Nail Solution exhibited destroyed organelles and many necrotic cells were found. The cell wall was clearly degraded and the contact between the cell wall and the inner membrane was punctured. In T. rubrum most cells were necrotic. Some cells were clearly collapsed and the content in the cytoplasm was degraded shown as small membrane vesicles and many big vacuoles. The cell wall was clearly degraded and the membrane was punctured. In conclusion, this in vitro study documents the efficacy of K101 Nail Solution against T. rubrum and C. albicans.

Treatment of seborrhoeic dermatitis of the scalp with a topical solution of urea, lactic acid, and propylene glycol (K301): results of two double-blind, randomised, placebo-controlled studies.

Alternative treatments for seborrhoeic dermatitis are needed because of the increasing risk of anti-fungal resistance to existing therapies. To investigate the efficacy, safety and tolerability of topical scalp treatment with K301 solution. Two multi-centre, randomised, double-blind studies were conducted. Study I: 4 weeks of once-daily treatment with either one form of K301 (a or b) or placebo, followed by 4 weeks of maintenance treatment three times-per-week. Study II: 4 weeks of K301 (a) or placebo once-daily. Study I: 98 patients enrolled (K301a + b, n = 51; placebo, n = 47) and 83 completed; 201 entered Study II (K301a, n = 136; placebo, n = 65) and 195 completed. Erythema and desquamation sum score at 4 weeks, mean (SD) values were 2.4 (2.0) for K301a + b and 3.2 (2.2) for placebo in Study I (P = 0.025) and 2.5 (1.9) for K301a and 3.2 (1.8) for placebo in Study II (not significant). In both studies, 4-week desquamation scores were significantly improved for K301 vs. placebo (P < 0.05). Both studies showed significant improvements in symptomatic investigator and patient assessments for K301 over placebo after 4 weeks (P < 0.05). Treatment-related adverse events were generally mild and included some smarting or burning upon application. The K301 was well tolerated and associated with clinically meaningful improvements in seborrhoeic dermatitis endpoints.